Source: http://www.gmp-compliance.org/eca_newsliste.html
Timestamp: 2013-05-20 02:15:30
Document Index: 573663948

Matched Legal Cases: ['art 1', 'art 3', 'art 3', 'art 11', 'art 11', 'art 2', 'art 3', 'art 3', 'art)\n119007', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art-11', 'art 11', 'art-11', 'art-11', 'art 11', 'art 11']

Nr.DateTitle
368508.05.2013Is there going to be "GMP Rating"?
367408.05.2013Results of ECA�s Validation Survey regarding the revision of Annex 15
367208.05.2013Written Confirmation: Australia gets on the List of "Third Countries"
366629.04.2013New FDA Guidance for the Prevention of Cross Contamination of Beta-Lactam Antibiotics
361229.04.2013New USP Chapter on Inhalation Drug Products
356529.04.2013Brazil's GMP Guideline Available in English
365925.04.2013FDA offers eLearning for eCTD Implementation
364425.04.2013EMA publishes Updated Procedural Advice for Centralised Marketing Authorisations
361025.04.2013CTD Format for Traditional Herbal Medicinal Products
366924.04.2013Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 - Quality Control
366324.04.2013EudraGMP Database now also comprises GDP Information
365124.04.2013Written Confirmations: Questions & Answers Document Version 4.1 published!
364724.04.2013FDA Guidance for Industry on Validation of Blood Establishment Computer Systems
365417.04.2013Written Confirmations: Time is running out - new EU Progress Report
364817.04.2013Change Control: New SUPAC Guidance published
364017.04.2013Comparison of EU GMP and Indian GMP Requirements for APIs
360617.04.2013Quality Standards on Recovered Solvents in the Manufacture of Herbal Medicinal Products
363510.04.2013FDA publishes GMP Requirements for "Combination Products"
361510.04.2013Sample Documentation on EU Site Master File published
359910.04.2013How many Validation Runs are State-of-the-Art today?
356610.04.2013Harmonisation of Bacterial Endotoxin Testing - ICH guideline Q4B Annex 14
362109.04.2013FDA publishes Draft on Medical Devices Recalls Guideline
361309.04.2013GMP for Medical Devices - ANVISA's Inspection Guide
357509.04.2013FDA's Strategies on the Regulation of Medical Products: How do they look like?
352609.04.2013How are FDA GMP Guidelines on the Regulation of Medical Devices made?
364104.04.2013Written Confirmations - How is the EU pharmaceutical Industry dealing with that?
360804.04.2013Future Quality Requirements on Essential Oils in Europe
360404.04.2013MHRA implements new Software for risk based Inspection Planning
359504.04.2013FDA Warning Letter on Water Purification
363403.04.2013Simplification of Application Submissions for Centrally Authorised Products
362903.04.2013WHO's New Draft Guideline on Submission of Quality Data for Generic Medicinal Products
363027.03.2013India issues Guidelines for Certification of API Exports to EU - can the EU accept this Certification?
362827.03.2013Second Publication of PDA's Technical Report on Process Validation
362427.03.2013Updated on Implementation of the Counterfeit Directive 2011/62 in the EU Countries
359327.03.2013New WHO Guideline on the Establishing of Hold Times of Intermediate and Bulk Products
359821.03.2013 Safety of Blood Components for Transfusion and of Stem Cell Products: Testing for HIV, HBV and HCV
359721.03.2013FDA Recommendations for Syphilis Screening of Blood and Blood Components
359621.03.2013Technical Update of Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors
362520.03.2013New Information on Written Confirmation from the EU Commission
361920.03.2013Revision of the GMP Matrix: US GMP vs. EU GMP
358620.03.2013Validation on the move: How should the Annex 15 of the EU GMP Guide be revised?
325920.03.2013Where can Indications on the Riboflavin Test be found? Are there any alternatives?
360312.03.2013Final Good Distribution Practices (GDP) Guideline published by EU Commission
352012.03.2013Why is GMP so important - Answers from the FDA
343412.03.2013AQL testing in the visual inspection of parenterals (FAQs)
358506.03.2013FDA seeks getting on the List of Third Countries with equivalent GMP Standards
358406.03.2013China Publishes New Good Distribution Practices
357806.03.2013ICH publishes New Draft Guideline on Genotoxic Impurities
356028.02.2013EDQM restricts the Acceptance of Substances for New CEP Applications
344328.02.2013European Medicines Agency recommends approval of first vaccine for meningitis B
358927.02.2013Are 300 GMP Inspections necessary by 2 July 2013?
357627.02.2013MHRA and NIBSC get new Structure on 1 April 2013
343227.02.2013FAQs concerning the visual inspection of Parenterals
355720.02.2013Good Distribution Practices for APIs - EU Commission Publishes Draft Guideline
354820.02.2013European Commission Publishes Extended Question/Answer Document on Written Confirmation
353520.02.2013India opens Drug Inspection Office in China
350620.02.2013SFDA rewards Whistleblowers
357318.02.2013Starting Materials and Intermediates
357218.02.2013Risk-based Approach to Advanced Therapy Medicinal Products
357118.02.2013Warning on transmissible Agents
357018.02.2013Isolation of Candidate Influenza Vaccine Viruses in Cell Culture
356918.02.2013Recombinant and Human Plasma-derived Factor IX Products
356818.02.2013Recombinant and Human Plasma-derived Factor VIII Products
356718.02.2013Plasma-derived Medicinal Products
355514.02.2013New EU Template for QP Declaration (IMPs)
354114.02.2013New Eudralex Vol.10 Guidance
352114.02.2013EMA issues Concept Paper for Antimicrobial Resistance Risk Assessment Guideline
351314.02.2013Responses to the public Consultation on the Paediatric Regulation
351114.02.2013New Guidance for Recall of IMPs
348614.02.2013FDA publishes List of planned Guidances for Medical Devices
347114.02.2013Regulatory Requirements concerning Quality Assurance of Medical Devices in Japan
346814.02.2013China-Europe: Information on Standards and Market Requirements
355313.02.2013Guidelines for formalised Risk Assessment of pharmaceutical Excipients issued
353813.02.2013Laboratory Data Integrity in FDA Warning Letters 2012
353713.02.2013WHO GMP approaching EU-GMP
352313.02.2013Up to $190.389 for FDA's New Inspections Fees
350313.02.2013Discussion of elemental Impurities in pharmaceutical Water
353006.02.2013Cross-contamination: Topic of the Revisions of Chapters 3 and 5 EU GMP Guideline
351506.02.2013PDA publishes Technical Report on Cleaning Validation
350706.02.2013Outcome of the public Consultation on the Review of the Variations Guidelines
349506.02.2013India Preparing for the Issuance of Written Confirmations
347806.02.2013New: ICH Q4B - Annex 13 on the Density of Powders
352830.01.2013Comparison (Matrix) of Former vs New Version of Chapter 1 of the EU GMP Guide Part 1 Effective from 31/01/2013
350930.01.2013Revision of Chapter 8 of the EC guide to GMP (Complaints and Recalls)
349930.01.2013New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation
347530.01.2013ECA Analytical Quality Control Working Group - Final OOS SOP
350029.01.2013FDA publishes three Guidances to facilitate Assessment/Submission of Medical Devices
349329.01.2013FDA publishes Draft Guidance on Design of Medical Devices
348329.01.2013GHTF ceases to work
351823.01.2013Revision of the EU GMP Guide: EU Commission Publishes Proposals for Chapters 3, 5, 6 and 8
348123.01.2013New GAMP Guide for Laboratory Computerized Systems
347423.01.2013USP plans Revision of General Notices Section of the Pharmacopoeia
347023.01.2013ICH Develops Another Pre-Step 2 Q3D Draft to Strengthen Consensus on Heavy Metal Standards
349117.01.2013FDA - Annual Fatalities Report FY2011
349017.01.2013FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus
348917.01.2013Measures to reduce the Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
348817.01.2013Recommendations for Donor Questioning, Deferral, Reentry and Product Management
348717.01.2013Pre-Storage Leukocyte Reduction
348517.01.2013Use of Nucleic Acid Tests
346416.01.2013New MHRA Q & A Document on the Import of Active Pharmaceutical Ingredients
345516.01.2013EMA publishes Reflection paper on Supply Shortages caused by Manufacturing/Good Manufacturing Practice Compliance Problems
345416.01.2013New EMA Guideline for Products with modified Active Substance Release
345216.01.2013Analytical Balances: New USP Proposals on Qualification
344809.01.2013Swissmedic - Information about the Plasma Master File in Switzerland
344509.01.2013CDER publishes "Review" of the Year 2012
293809.01.2013Significant Guidelines regarding Veterinary Medicinal Products
345019.12.2012New Method to Directly Sequence Small Genomes Without Library Preparation
344919.12.2012New USP Publication: Monitoring Humidity during Transportation?
344219.12.2012PIC/S issues Update of GMP Guide
342112.12.2012Swiss GMP standards and inspection equivalent to EU
339412.12.2012FDA provides information about influence of wheather conditions on biological products
342805.12.2012USP Postpones the Publication of General Chapters <232> and <233> on Metallic Impurities
342605.12.2012EMA publishes Concept Paper on the Revision of Annex 15
342305.12.2012New Concept Paper on Annex 17 of the EU GMP Guide
341928.11.2012Pharmaceutical Standards in Israel and EU Equivalents
341528.11.2012ECA publishes Good Practice Guide on Process Validation
341128.11.2012How to Manage Efficiently Annual GMP Trainings?
341221.11.2012FDA-approval for Roche�s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL� PCR Mycoplasma Detection Kit)
340821.11.2012ICH plans Q&A on ICH Q7
340421.11.2012New guideline for DNA Sequences could prevent erroneous Data
340321.11.2012News from the PIC/S
338221.11.2012Revision of USP 1223 - current Status
341320.11.2012Rapid Micro Biosystems announces Availability of Growth Direct System
339315.11.2012EMA announces streamlining of activities of Committee for Advanced Therapies
332315.11.2012Commitee for Advanced Therapy Medicinal Products (CAT) - Public Call for Expression of Interest
340714.11.2012New EMA Q&As on Genotoxic Impurities
339914.11.2012Medical Devices Warning Letter Statistics 2012 - Rank 1 for CAPA and Complaint Files
336614.11.2012New EU-GMP Chapter calls for Continuous Improvement
339607.11.2012Changes to Variation Rules started to apply
339107.11.2012New EMA Guideline on Specifications for Impurities in Antibiotics
338807.11.2012GMP Compliance Problems may cause Drug Shortages
334506.11.2012EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines
333706.11.2012Literature and publications list are updated with 11 publications
333606.11.2012RMM database updated with new systems
338631.10.2012EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation
338131.10.2012WHO issues Update of Pharmaceutical Water Guideline
337431.10.2012DataMatrix Code on Pharmaceutical Packaging - Pilot Project starting in January
336530.10.2012Modification of ISO 13485 - new Annexes ZA, ZB and ZC
336430.10.2012QP for Manufacturers of Medical Devices - New EU Requirement?
335330.10.2012New rules for Medical Devices published by the EU - significantly tightened Controls planned
337624.10.2012FDA Warning Letter Statistics 2011 with regard to Process Validation / Qualification and Calibration
337024.10.2012EMA on Track to meet Targets
336224.10.2012Draft Guideline on Good Distribution Practices for Biological Products published by CDSCO
336917.10.2012WHO publishes revised Draft Guideline on Quality Risk Management
335717.10.2012Additional Guidance Document on Active Substance Master File (ASMF) published by EMA
335517.10.2012FDA requires Registration of Manufacturing Facilities until December 2, 2012
326417.10.2012Handling of Deviations and CAPA criticised by Inspectorates
334411.10.2012FDA publishes Draft Guidance on Stability Testing of Generics
334211.10.2012Generic Drug Applications in the USA: Completeness Assessment of Drug Master Files for APIs by the FDA
333210.10.2012GMP Matrix as Standard for Audits in many Companies
329010.10.2012Questions and Answers of the Japanese Regulatory Authorities regarding Computerized Systems
293310.10.2012What are the consequences if an API manufacturer has not been audited?
335009.10.2012US Government Report on Innovation in Pharmaceutical Development
334709.10.2012European Commission seeks Feedback on Paediatric Regulation
334609.10.2012Update of FDA Clinical Investigator Inspection List
333004.10.2012Which Types of Third Party GMP Audits may be used - which not?
332404.10.2012Chinese API Manufacturers revealed to have used gutter oil for the Manufacture of Antibiotics
331104.10.2012Qualified Person Association Database for Shared Audits "QPSHARE" comprises 284 API and Excipient Suppliers
330604.10.2012ISPE Guide bridges traditional Qualification and risk- and science-based Qualification
331001.10.2012FDA confirms Deadline for Application of QbD for Generic Drug Manufacturers!
329801.10.2012FDA Dissolution Methods Database
327801.10.2012Interesting Case Study on Quality by Design for Vaccines
327401.10.2012EMA explains EU Incident Management Plan for Human Medicines
325501.10.2012EMA recommends first Gene Therapy for Approval
331827.09.2012The new EU GMP Chapter 1 in Pharmaceutical Development
330427.09.2012FDA Requirements on Bioequivalence Data for Generic Drug Products
332526.09.2012EU: new Delegated Act on Shipments of Medicinal Products through EU
330726.09.2012The new EU Good Distribution Practices (GDP) Guideline - What will happen next?
329526.09.2012ISPE Mapping Document explains Relationship between different Qualification Guides
333519.09.2012The new EU GMP Guide Annex 2 - a brief Content Summary
332819.09.2012Extension of Directive 2003/94/EC to GMP for APIs - EU Commission publishes Comments on Concept Paper
330219.09.2012Dissolution Testing of new and special Dosage Forms - Updated FIP/AAPS Document
329219.09.2012EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations
328919.09.2012Actual GMP Deficiencies concerning Validation/Qualification/Calibration as seen by the MHRA
328719.09.2012Japanese Requirements on Computerised Systems
326519.09.2012cGMP: SOP Management and Training criticised by FDA
332012.09.2012Finally published: new EU GMP Chapter 7 on Outsourced Activities
331612.09.2012Finally published: new EU GMP Chapter 1 with comprehensive Changes
331512.09.2012GMP Guideline Annex 2 revised
330012.09.2012USP Standard for Dissolution Testing withdrawn
326312.09.2012ICH Q8, Q9, & Q10 Questions and Answers - now also in force in the USA
328505.09.2012FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI)
327005.09.2012Chinese SFDA issues new Regulation on a strengthened Supervision of Pharmaceutical Excipients' Manufacturers
328404.09.2012IEC 60601-1 valid in 3rd Version since June 2012 - Risk Management playing important Role
328304.09.2012Will there be a Registration Obligation for critical Medical Devices?
328104.09.2012New Guide for Manufacturers of Stand Alone Software
326830.08.2012Novel Manufacturing Strategy: Continuous Manufacturing - Development Case Study
327129.08.2012New Templates for GMP and GDP certificates published by EMA
326122.08.2012Continuous Manufacturing - FDA Perspective on Submissions and Implementation
325322.08.2012Curved Calibration Functions - how to perform the Regression Calculation?
324022.08.2012FDA Expectations concerning Real Time Release Testing (RTRT)
323822.08.2012New EMA draft on NIRS
322622.08.2012USP Article about new USP NIR System Suitability Reference Standard
321522.08.2012New EMA Guideline on Real Time Release Testing
325415.08.2012FDA Warning Letters relating to Computerised Systems
324115.08.2012EMA publishes Video explaining the new Pharmacovigilance Legislation
325014.08.2012New Rules for the Importation of APIs - a European Commission Leaflet provides Information
324914.08.2012Dr. Claudius Micha N�bling becomes Member of the RMM Group Advisory Board
324814.08.2012New Additions to the Literature List on ECA's RMM Website
324714.08.2012Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research
324314.08.2012More Flexibility in Sterility Testing of biologic Products � FDA Amendments
323514.08.2012Draft on New GCP Directive 2001/20/EG
323114.08.2012EDQM publishes Guidance on Notifications of Changes of CEPs
321814.08.2012GDUFA: New Fee Act for the Generic Drugs and APIs Industry adopted by the Congress
321014.08.2012ATMP - EMA Reflection Paper on Classification of Advanced Therapy Medicinal Products
320914.08.2012Revised Guideline on Renewals in the Centralised Procedure Effective!
320414.08.2012FDA Approves OTC HIV Test for the First Time
320214.08.2012FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing
319714.08.2012FDA issued 8 Warning Letters to Companies because of Missing Establishment Registration
319014.08.2012Will there be an Authorisation Obligation for Critical Medical Devices?
312314.08.2012New Homepage of ECA's Rapid Microbiological Methods Working Group
312214.08.2012 ECA's Rapid Microbiological Methods Conference
312114.08.2012Case Study of New Growth-based Rapid Microbiological Method (RMM) detects the Presence of Specific Organisms
323301.08.2012Top 10 Deficiencies - Applications for Certificates of Suitability (CEP)
322701.08.2012Revised Guideline on the ASMF Procedure Coming into Force on 1st October 2012
321901.08.2012Another Third Party GMP Audit performed in Germany by API Compliance Institute
322925.07.2012Continuing Trend: Again, Numerous Warning Letters issued to European API Manufacturers
322225.07.2012More GMP Inspections by EMA due to Increasing Quality Issues
320725.07.2012How to set Specifications for Genotoxic, Metallic Impurities and Residual Solvents in APIs?
320025.07.2012New Guide for Manufacturers of Stand Alone Software
321111.07.2012EU GMP Part 3: New Final Document on Written Confirmation
319211.07.2012USP's Position to the Glass Particles Issue
318711.07.2012FDA - S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
318611.07.2012FDA issues Amendment to the Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products
319404.07.2012New Guidelines on Good Pharmacovigilance Practices released
318904.07.2012MHRA publishes GMP Deficiency Data Review April 2011 - March 2012
318404.07.2012USP Chapter <62> Frequently Asked Questions
318527.06.2012FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus
316727.06.2012APIs from China and India - will Import go down in 2013?
318020.06.2012Revision of the Guidelines on Category Variations to the terms of Marketing Authorisations- EU Commission releases Public Consultation Paper
317420.06.2012EMA updates "Compilation of Community Procedures on Inspections and Exchange of Information"
316920.06.2012Audit Tools and Checklists for Good Distribution Practices
316620.06.2012Revised Guideline Draft on Biosimilar Medicinal Products published
316313.06.2012News PIC/S Structure
315713.06.2012FDA starts Voluntary Audit Report Program for Medical Devices
313413.06.2012Two Third Party GMP Audits performed in Germany by API Compliance Institute
300613.06.2012FDA identifies 22 Chinese companies out of GMP compliance
316006.06.2012Half-year Report 2012: FDA Medical Devices Warning Letter Statistics
315506.06.2012Important Notice from the EDQM to CEP Holders - Warning of Fraudulent Invoices
315206.06.2012EMA: Practical Guidance on Implementation of Pharmacovigilance Legislation published
315106.06.2012New IMPD Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials
305805.06.2012New USP Chapter <1083> on Good Distribution Practices
305205.06.2012GMP Requirements for Pharmaceutical Excipients: NSF International publishes new Draft Standard
303805.06.2012FDA publishes Draft Guidance on Clinical Studies for Medical Devices
303505.06.2012FDA's new Guidance Documents for 2012
314930.05.2012Current State of Harmonisation (EP/USP/JP)
314630.05.2012Rx-360 releases New Checklists
314430.05.2012Quality documentation concerning biological investigational medicinal products in clinical trials
314230.05.2012Incorrect Handling of OOS Results found in 10 FDA Warning Letters in 2011
314323.05.2012OOS Results - Very helpful Q&As published on the MHRA Website
313123.05.2012New Developments at EP, USP an JP - Divergent Compendial Methods and Harmonisation
311623.05.2012New ECA Working Group on Process Validation starts first Project
311223.05.2012Detailed Analysis of EMA's new Draft on Process Validation
314116.05.2012Development and Manufacturing of APIs: Final ICH Q11 Document Published!
313316.05.2012New USP Chapter on Method Transfer effective
313016.05.2012Which Information on Stability of Pharmaceutical Bulk Products is required in the Application Dossier?
312716.05.2012Foundation of a new French Health Regulation Authority
312016.05.2012Interesting USP Validation Documents - Available Online free of Charge!
310116.05.2012EMA strengthens Oversight on Clinical Trials outside EU
308616.05.2012EMA - Regulatory procedural Advice on similar biological medicines
311309.05.2012FDA Compliance Programme Guidance on Inspections of Medical Devices Manufacturers
311109.05.2012The new EMA's eSubmission Gateway for Centralised Authorisations is released!
309309.05.2012New GAMP Good Practice Guide for Risk-Based Approach to GxP Compliant Laboratory Computerised Systems: Due for Publication in June
309009.05.2012FDA Update
310903.05.2012Import of APIs from Third Countries into the European Union: Template for the written Confirmation of GMP Compliance published for Comments
310703.05.2012New EMA Questions and Answers Document on Post Approval Change Management Protocols
308303.05.2012FDA amends wording in the CFR for Label Control Provisions for certain Label Types
307903.05.2012FDA wants to facilitate Drug Development with new Tools
301203.05.2012New FDA Online Training on GMP for Medical Devices
309925.04.2012Several API manufacturers in China, India and Brazil found out of GMP compliance
309825.04.2012EMA publishes Draft on the Process Validation Guideline
309625.04.2012Interesting FDA Presentation on Supply Chain Integrity
308525.04.2012Maintaining Laboratory Computer Validation - How to Conduct Periodic Reviews?
307525.04.2012Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 4
308418.04.2012Track & Trace: SecurPharm Pilot Project now also considers the GS1 Standard
307418.04.2012Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 3
307018.04.2012How to Implement Design Control for Combination Products within Pharma?
306618.04.2012EU Clinical Trials Register in co-operation with WHO
308211.04.2012FDA: Ensuring the Safety of Vaccines in the United States
307811.04.2012PIC/S publishes Aide-Memoire on Inspection of Risk Management Systems
307211.04.2012Questions & Anwers on EU GMP Guideline Annex 11 "Computerised Systems" - chapters 1-2
306511.04.2012New EMA Reflection Paper on Heparin and further Biological Starting Materials
306304.04.2012Significant Changes in HPLC System Suitability: New USP Provisions Planned
306004.04.2012American Pharmaceutical Association suggests its own Model for Track and Trace
304504.04.2012The new role of the Responsible Person for Good Distribution Practices
303304.04.2012International Collaboration on Good Manufacturing Practice Inspections expanded
305121.03.2012The EDQM eTACT Project for an Anti-Counterfeiting Traceability Service for Medicines
304121.03.2012Data Integrity Problems as key Issue for Ranbaxy's Consent Decree
303221.03.2012New Requirements for the Submission of Information on Medicinal Products - EMA publishes New Guidance for MAHs and a revised "Legal Notice"
301321.03.2012ISPE Guide assists modern Qualification
303014.03.2012Regulatory Monitoring of API Manufacturers - FDA, TGA, EMA and EDQM express Common Objectives for Inspections Collaboration
302714.03.2012Transitional Regulations for the New Pharmacovigilance Package: Commission's Q&A Document provides Clarity
302214.03.2012FDA's new web-based Training explains FDA Drug Regulatory Work
299114.03.2012PIC/S asks Inspectors to have a look at Job Cuts
302507.03.2012EMA Reflection Paper on Sourcing Biological Starting Materials
299407.03.2012How to Integrate Analytical Instrument Qualification and Computerised System Validation?
297807.03.2012FDA - New draft guidances for Biosimilars
295307.03.2012New Chinese GMP rules published in English
299829.02.2012HPLC in FDA Warning Letters
298629.02.2012FDA Draft Guidance: How to qualify Heparin Suppliers
298129.02.2012Safety Features & Drug Authentication: Which System will prevail?
297429.02.2012Bio Assays - Commentary � First Supplement to USP 35-NF 30
298322.02.2012Medical Devices: European Commission calls for Immediate Actions - Tighten Controls, Increase Surveillance
297622.02.2012EMA works on Recalculation of Limits for Cleaning Validation
297222.02.2012EU Commission publishes Feedback on New Good Distribution Practices (GDP) Guide
296022.02.2012FDA Generic Drugs Office Advances QbD, Review Processes and QM System in Anticipation of User Fees
296815.02.2012Revision of the European Variations System: EU Commission publishes the Outcome of the Public Consultation
296315.02.2012EMA counts down to Introduction of new Pharmacovigilance Legislation
294015.02.2012Publication of the Danish Medicines Agency about Requirements regarding Updates of Active Substance Master Files
292215.02.2012Overview of FDA Warning Letters regarding the Manufacture of Sterile Medicinal Products
289815.02.2012EMA Guideline on Quality of Herbal Medicinal Products Updated
286115.02.2012ECA Analytical Quality Control Working Group - Final OOS SOP
296908.02.2012EXCiPACT - A new Certification Scheme for Excipients has been launched
296608.02.2012New Questions and Answers about the Centralised Procedure - EMA publishes an Updated Q&A Document
294708.02.2012Good Distribution Practices (GDP) adopted by PIC/S
294508.02.2012Joint Statement of the EFPIA, GIRP and PGEU regarding Falsified Medicines
290108.02.2012New EMA Guideline on Specifications for Herbal Medicinal Products
295801.02.2012GMP for Medical Devices - Lessons learnt from the PIP Scandal?
295201.02.2012Significant Administrative Changes in the New Revision of the Guideline on the ASMF Procedure
294901.02.2012FDA: QbD becomes mandatory for Generics
294225.01.2012Extension of Directive 2003/94/EC to GMP for APIs - EC Commission publishes Concept Paper for Comment
293225.01.2012Short-term Revision of USP Chapter on Dissolution Testing
291725.01.2012Pharmeuropa publishes a Draft Monograph on "Biological Indicators"
289925.01.2012Report of the HMPC Meeting held in November 2011
293018.01.2012Inadequate Validation of Analytical Methods remains permanent Topic in Warning Letters to API Manufacturers
291518.01.2012Archiving of Paper and Electronic Data of great Concern for FDA and EU Authorities
289518.01.2012New ISPE Guide on Process Gases
292412.01.2012GMP non-Compliance causes further CEP Suspensions
290912.01.2012New Version of ISO 19011 on Auditing published
290512.01.2012ICH Q11 close to final Approval
290412.01.2012EMA, CVMP - Testing of Mycoplasma Contamination
290603.01.2012IPEC publishes GDP Audit Guideline for Pharmaceutical Excipients
289103.01.2012Drug Master Files (DMF) - Recorded Webinar with FDA Dr Arthur B. Shaw
287703.01.2012USP elaborates Guidelines to limit Counterfeit Medicines
288921.12.2011IMB publishes Guide on GDP (wholesale distribution)
288721.12.2011New FDA and EMA Initiative allows mutual Recognition of Inspections
288514.12.2011ICH Publishes Additional Q8/Q9/Q10 Points to Consider
288314.12.2011Anti-Counterfeiting Directive requires Import Certificate for the Import of APIs from Third Countries into the EU
286814.12.2011Screening of Frequent Donors of Blood and Blood Components
286607.12.2011New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products
286307.12.2011Archiving of Chromatograms: FDA provides important Clarification
285907.12.2011CEP Suspensions and Withdrawal due to GMP Deviations
287430.11.2011USP publishes First Ten Quality Standards in New Medicines Compendium
287230.11.2011"Production Record Review" - The most frequently cited Paragraph in FDA Warning Letters
287030.11.2011Twelve Countries sign Medicrime Convention on Counterfeit Medicines
286730.11.2011FDA wants to streamline the Classification of Blood and Plasma Recalls
285623.11.2011EMA publishes Concept Paper on Dedicated / Shared Facilities
267823.11.2011WHO issues revised version of HVAC Guide
285116.11.2011New Concept paper on Annex 16 of the EU-GMP Guide
284816.11.2011FDA publishes Q8/Q9/Q10 Implementation Document
283116.11.2011FDA Guideline on Anticounterfeiting Medicines
284309.11.2011European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation
284009.11.2011New QP Declaration for managing Expiry Dates of IMPs
283809.11.2011MHRA announces Good Clinical Practice (GCP) Discussion Forum
283709.11.2011Medical Devices Warning Letter Statistics 2011
283402.11.2011International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making
281802.11.2011First ECA/EQPA Conference in the U.S. a great Success
281502.11.2011FDA Inspectional Observations on Hygiene, Cleaning and Sanitation
280802.11.2011GHTF publishes Guidance on Globally Harmonised Identification of Medical Devices
282526.10.2011FDA Draft Guidance regarding Media Fills for PET Drugs
282226.10.2011FDA defines 25 SOP provisions required by CFR
282126.10.2011FDA publishes List of Guidance Documents for Medical Devices
281126.10.2011CHMP adopts Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses
282820.10.2011EU Commission publishes a New Document about Duplicate Marketing Authorisation Applications
280920.10.2011FDA strives for more Transparency regarding GMP Compliance and Enforcement Data
280020.10.2011FDA Q&As on pathogenic Contamination of animal-derived Drug Ingredients
272420.10.2011Summary of FDA 483 Inspectional Observations
277213.10.2011Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005-2010 Revision Cycle
275312.10.2011Technical Report - Assistance for Biotechnology Cleaning Validation
280605.10.2011EMA Reflection Paper provides Concrete Information about Risk based Quality Management
280205.10.2011Extension of the Variations Regulation to Purely National Authorisations coming: new Consultation Paper published by the EU Commission
277705.10.2011New FDA Requirements regarding Tablet Splitting
279928.09.2011EMA's Current Positions on Transfer of a Marketing Authorisation
279528.09.2011FDA's Current Position about Melamine Contamination in Pharmaceutical Excipients
275028.09.2011EMA Reflection Paper on risk based Quality Management in Clinical Trials
279021.09.2011EMA publishes two advisory Documents addressing a Number of Questions about centralised Admission Procedures
271621.09.2011ICH Q4B - Annex 7(R2) on "Dissolution Testing" becomes binding in the USA too
240921.09.2011FDA criticises SOP Training in pharmaceutical Companies
278414.09.2011New: Revised USP Monographs of Spectroscopic Methods
277414.09.2011EDQM gives Clarification concerning Stability Data for APIs within the Certification Procedure
271214.09.2011Expiry Dating for Reagents and Solutions in Laboratories: What are FDA's Expectations?
276109.09.2011Faster Sterility Tests for Biological Products
276009.09.2011Rapid Methods - Influence of FDA's Strategic Plan for advancing Regulatory Science
277107.09.2011Revision of USP 231 "Test for metal Catalysts" - what will change?
276707.09.2011German Initiative 2D Matrix Code SecurPharm started on 31 August!
276407.09.2011European QP Association forms Expert Panels
275607.09.2011EMA Reflection paper on IVR/IWR systems
271407.09.2011USP and FDA strengthen Collaboration
274131.08.2011FDA withdraws Guideline on Validation of LAL Test
273131.08.2011Report on the joint Good Clinical Practice (GCP) Inspection Pilot Programme
272831.08.2011FDA Courses and Tests now available online
272331.08.2011Result of EDQM Expert Meeting on Manufacture of WFI by Membrane Process
274824.08.2011EU GMP Guide: New Requirements added for Batch Certification
273024.08.2011FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications
270824.08.2011Official Tips for preparing an initial Drug GMP Inspection
269824.08.2011New WHO guidance for Storage and Transportation
273517.08.2011Final Report on the International API Inspection Programme published
273417.08.2011EMA Guideline on bioanalytical Method Validation adopted
272017.08.2011EMA Position Statement on Creutzfeldt-Jakob Disease and advanced Therapy medicinal Products
268817.08.2011EMA: New Guideline on Development of Medicines for Paediatric Use
263317.08.2011ECA Foundation Board Annual Meeting Report
271910.08.2011Urgent Revision of EP 5.2.8. Minimising the Risk of Transmission of animal Spongiform Encephalopathy
270210.08.2011Revised EU Guideline on Good Distribution Practice with major Changes
270110.08.2011ECA Analytical Quality Control Working Group - OOS SOP Development
269610.08.2011EU Product Quality Review now also part of WHO GMP main Principles
268010.08.2011New WHO Document on Transfer of Processes with detailed Guidelines for Analytical Method Transfer
265410.08.2011ECDC - Technical Report on the Prevention of Creutzfeldt�Jakob (vCJD) published
265210.08.2011New PIC/S Q&A Document regarding Distribution Activities for APIs
262910.08.2011FDA publishes SOP for "Notice to Industry" Letters for the Medical Devices Industry
266708.08.2011WHO in charge of Qualifying QC Laboratories for the UN
265908.08.2011WHO Technical Report incuding Annex 2 "Good Practices for pharmaceutical microbiological Laboratories"
265808.08.2011FDA proposes Changes in Sterility Testing of Biological Products
271003.08.2011New EMA Draft Guideline on Stability Data regarding Applications for Variations to a Marketing Authorisation
269403.08.2011EMA publishes Compilation of Community Procedures on Inspections and Exchange of Information
268603.08.2011New FDA Draft Guidance regarding Design Development of Medical Devices
268227.07.2011Warning of Potential Contamination with Toxic Plasticizer
267727.07.2011MPA Proposal: No GMP Certificate in Case of Violation of environmental Constraints
265327.07.2011New FDA Guidance on Dosage Delivery Devices (measuring Spoons, Droppers, etc.)
264127.07.2011Which kind of GMP Documentation is needed for an API Manufacturer who performs Sterilisation of an active Substance
261727.07.2011FDA publishes Analysis of 2010 Warning Letter Statistics regarding Medical Devices
269020.07.2011EU Commission publishes important new Draft Guideline on Good Distribution Practice of Medicinal Products for Human Use
268320.07.2011New: ICH Guideline for ICH Q8, Q9 and Q10 implementation
266920.07.2011WHO publishes Notice of Concern regarding GMP Deviations about two Manufactures located in India
266620.07.2011Quality by Design for Generics - Case Studies
267413.07.2011Excipact™ - the Certification Scheme for Pharmaceutical Excipients
266413.07.2011Revision of the General Chapter NIR in PHARMEUROPA
265613.07.2011The Falsified Medicines Directive published in the Official Journal of the European Union
264313.07.2011FDA publishes Draft Guidance on Classification of Products as Drugs or Devices
264906.07.2011New Guideline on EMA Certificates of Medicinal Products
263806.07.2011FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices
262206.07.2011Contract Manufacturers and Contract Laboratories do no longer need to be pre-approved by DMA
262006.07.2011FDA's membership of PIC/S - why it is important
264429.06.2011FDA plans on publishing further GMP and CMC Guidances for Combination Products
263729.06.2011Pfizer transfers first QbD Dossier within the FDA/EMA Project
263529.06.2011FDA announces New Worldwide Strategy on GMP Supervision and Importation
261329.06.2011Audio Presentation of ICH Q8, Q9 and Q10 now available
261921.06.2011New ICH Q11 Guideline published
260021.06.2011Why did FDA change their Guideline on Process Validation?
261116.06.2011FDA creates "Super Office" for better GMP Monitoring and Fight against Counterfeit Medicines
260416.06.2011New EMA Concept Paper on Process Validation of Biotechnology derived active Substances
259508.06.2011How compliant is your supplier? FDA establishes new Online Inspection Database
258708.06.2011Modernisation of USP Monographs
259101.06.2011In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens
258801.06.2011The Council of the European Union adopts Falsified Medicines Directive! Major challenges for Users and Producers of APIs and pharmaceutical Excipients to be expected
257801.06.2011EMA Report on Clinical Trials outside the EU
258425.05.2011The 4th European GMP Conference a great Success - Read more about major GMP Developments
258225.05.2011FDA publishes annual Fatalities Report regarding Blood Collection and Transfusion
258125.05.2011The Challenges of Ensuring Laboratory Data Integrity
257518.05.2011Suspension and Withdrawal of CEPs by EDQM
257318.05.2011New Annex 14: Consequences for QPs
257018.05.2011FDA asks how to improve existing Regulations
256811.05.2011EMA: Monitoring of Products originating from Japan for the Possibility of Radioactivity
256711.05.2011Quality by Design for pharmaceutical Excipients - IPEC publishes new Checklists and Q&A Document
255811.05.2011EP 2.6.31. Microbiological Examination of herbal medicinal Products for oral Use under Revision
255611.05.2011FDA's Strategic Priorities 2011 - 2015 now available
254511.05.2011EMA's answers to FAQ on Computerised Systems
255104.05.2011New PIC/S Document on GMP for APIs
240504.05.2011CAPA among the most frequent GMP Deviations cited in FDA Warning Letters
254828.04.2011Nuclear Load of pharmaceutical Products from Japan
253928.04.2011Revision of Chapter 8 of the EC guide to GMP
249928.04.2011EDQM's Enquiry on the new Draft of a general Chapter on Uniformity of Dosage Units
254120.04.2011Risk Management Principles used for WHO Inspections of API facilities
253420.04.2011EDQM requires more Information on the Manufacturer's Localisation (DUNS/GPS) for CEPs
252220.04.2011New Guidance on Investigational Medicinal Products (IMPs) and Non Investigational Medicinal products (NIMPs)
251620.04.2011Note for Guidance on minimising the Risk of transmitting Animal Spongiform Encephalopathy Agents via human and veterinary Medicinal Products
253713.04.2011New Limit regarding unspecified Impurities for certain Substances - EDQM Updates respective CEPs
251913.04.2011New answers published about Variations: EMA's updated "Post-Authorisation" Guideline
250513.04.2011Quality IWG Training Material on ICH Q8, Q9 and Q10
252506.04.2011May unvalidated Methods also be accepted to test Drug Products? - The FDA answers
251206.04.2011New EMA Checklist should help Type IA Variation Submissions
250306.04.2011EMA and FDA announce Pilot Program for Assessment of QbD Applications
241006.04.2011Annual Product Review (APR) as GMP Deviation in FDA Warning Letters
252030.03.2011Video Presentation from FDA�s Dr Moheb Nasr available
251430.03.2011Dedicated Facilities: FDA publishes Draft Guideline
250230.03.2011News IPEC-Americas "Distributors Audit Guide" for Pharmaceutical Excipients
249230.03.2011New Compilation of Community Procedures on Inspections and Exchange of Information
240430.03.2011Production of WFI through Membrane Processes: Survey Results
248625.03.2011Results of Survey on EU GMP Guide Revisions of Chapter 5 (Production) and 7 (Contract Manufacture and Analysis)
248225.03.2011FDA Warning Letter Statistics 2010 regarding Process Validation and Qualification
244425.03.2011Requirements on Validation of Sterilisation Procedures according to ISO 17665-1
243225.03.2011Surveillance of Medicinal Products- Annual Report of the German Federal States
249016.03.2011China's new GMP Regulation effective since March 1, 2011
246916.03.2011Amended Directive 2001/83/EC includes stronger Guidance on GMP for APIs and Excipients
245716.03.2011FDA: Applications to contain Information described by ICH Q8
241616.03.2011EMA plans on focusing more on API Manufacturers located in Asia
241116.03.2011FDA focuses more on Supplier Qualification
246009.03.2011New FDA Guidance Documents in Calendar Year 2011
245009.03.2011Evaluation of the Warning Letters issued by the FDA for the Fiscal Year 2010 with regard to Risk Management
243809.03.2011Quality Agreement templates for every Participant of the 4th European GMP-Conference
243409.03.2011FDA and EMA Pilot Program for joint Review of QbD Components of new Drug Marketing Applications
241509.03.2011EMA plans extensive Revision of the EU GMP Guide
246503.03.2011Inspection of API manufacturers: First Results of the WHO Pre-Qualification Programme
245403.03.2011"Impurities: Guideline for Residual Solvents Q3C(R5)" has been finalised
245103.03.2011Aide memoire of German Inspectors now also available in English
243703.03.2011Validation on Rank 3 in the FDA Warning Letter Statistic 2010 regarding Medical Devices
240703.03.2011Batch Record Review as GMP Deviation cited in FDA Warning Letters
246701.03.2011EMA adjusts Fees for Marketing Authorisation Applications
245201.03.2011ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components
242601.03.2011Concept Paper on the Revision of the GCP Directive published
239301.03.2011IMPD: EMA provides further Clarification for Quality of IMPs
237101.03.2011Specific WHO Requirements for Dissolution Studies to Support Biowaivers
242924.02.2011Revision or Renewal of CEPs: Requirements for Notifications to the EDQM
242724.02.2011EU-GMP Guide: New Introduction with Clarification of Status of Part III
242324.02.2011"Q3D: Impurities: Guideline for Metal Impurities" - a new ICH Concept Paper
235524.02.2011Guideline on Testing for the Detection of Mycoplasma Contamination of veterinary medicinal Products
234324.02.2011New EMA/HMPC Reflection Paper on Stability of Herbal Medicinal Products
232724.02.2011DMA Document on Expectations for Audits of API Manufacturers
240022.02.2011Updated Q&A Document on the Submission of Variations published
239122.02.2011EDQM develops Live Demo for a Track & Trace System
238622.02.2011EMA publishes final �Road map to 2015�
237322.02.2011New Pharmacovigilance Legislation adopted
235422.02.2011Discussions about Material Certificates
234122.02.2011EMA/HMPC Reflection Paper on Extracts Purification
232322.02.2011USP <85>Bacterial Endotoxin Test - proposed interim Revision Announcement
240117.02.2011In-depth analysis of the requirements on the new EU / PIC/S Site Master File
239717.02.2011FDA takes action against non-compliant manufacturer
239517.02.2011The number of Warning Letters issued to Drug Companies and API Manufacturers increases
235617.02.2011FDA launches Basics for Industry Website
234517.02.2011Quality of Herbal Medicinal Products - Current EMA/HMPC Q&A Document
233017.02.2011Results of the Survey "Implementation of the new Annex 1 requirements for Capping"
243916.02.2011New Pharma Directive on Counterfeit Medicine adopted by EU Parliament
242010.02.2011New version of EudraGMP allows access to information from all Member States
241810.02.2011EMA publishes ICH Q9 and ICH Q 10 as Part 3 of the EU GMP Guide
236810.02.2011Growing Requirements on Process and Technology Transfers
235910.02.2011EMA publishes two documents on the QP Declaration concerning GMP Compliance of the API
234810.02.2011PIC/S SMF Guide Updated with Quality Management System Requirements
238002.02.2011Detailed Analysis of FDA�s New Process Validation Guidance
236902.02.2011Warning Letters Report 2010: Laboratory Controls and Analytical Methods again among Top Five GMP Deviations
236302.02.2011Clean Room Classification: Draft on ISO 14644 published
234602.02.2011News published about Guidance on Combating Counterfeit Drugs
238427.01.2011FDA publishes Final of new Process Validation Guidance
238127.01.2011The New GMP Annex 11 and Chapter 4 is Europe's Answer to Part 11
233127.01.2011Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms
231827.01.2011EDQM strengthens international Collaboration
236119.01.2011New EU GMP Guide Chapter 4 on Documentation
235219.01.2011New EU GMP Guide Annex 11 "Computerised Systems"
233219.01.2011Compliance Policy Guide: RFID Studies and Pilot Programs for Drugs
231419.01.2011ICH Q8, Q9 und Q10: new Q&A Document published
232412.01.2011New FDA Guidance: Codevelopment of Investigational Drugs for Use in Combination
232112.01.2011USP <1113> Microbial Identification - In Process Revision including a title change
231012.01.2011New Best Practice Guides for the Submission and Processing of Variations published
230812.01.2011FDA Inspections: Current Initiatives
232205.01.2011Complete Revision of USP Chapter <1116> including updated Cleanroom Classification
231605.01.2011FDA issues Guidance on Public Comment Procedures at Advisory Committee Meetings
231322.12.2010Verification of Compendial Procedures - Changes Planned in the USP General Chapter <1226>
230722.12.2010Pharmacopeial Forum (USP) going online and free
230415.12.2010Revision of Chapter 6 of the EU GMP Guide Quality Control - New Concept Paper
230215.12.2010What Information on Impurities is necessary for a Marketing Authorisation Application for a generic Medicinal Product in the US?
229715.12.2010ICH Q7 How to do Guide - Video Presentation of APIC Conference available
229008.12.2010EMA Concept Paper on Storage Conditions during Transport
228508.12.2010New EMA Guideline on the Investigation of Bioequivalence
227808.12.2010Frequently asked Question: How do I find all CEPs suspended by the EDQM?
227308.12.2010Concept Paper: Quality Management Challenges in Pharmaceutical Industry
228001.12.2010Will there soon be a shortage of QPs?
227201.12.2010FDA publishes Report on Third Party Audits of Medical Device Manufacturers
226701.12.2010Questions and Answers on the 'Guideline on the Limits of Genotoxic Impurities'
228825.11.2010European Commission issues new Draft of Chapter 5 "Production" of the EU GMP Guide
227725.11.2010FDA becomes official member of PIC/S
227025.11.2010ISPE publishes new Baseline on the Subject of Risk Management
226025.11.2010USP completes Evaluation of Recall of USP 33
226917.11.2010ECA establishes new Working Group - Invitation to get involved
226517.11.2010"Outsourced Activities" - Revision of Chapter 7 of the EU GMP Guide
225717.11.2010Important revision of ISO 14644-1: Clean Room Classification is likely to be changed
224917.11.2010FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus
225410.11.2010GMP Problems cause the Suspension and Withdrawal of further CEPs
224710.11.2010New FDA Guidance on the Development of Transdermal Systems
224108.11.2010PDA published Technical Report No. 50, Alternative Methods for Mycoplasma Testing
225303.11.2010FDA, EMA and TGA Inspection Programme with impressing Result
224403.11.2010FDA drafts Guidance on the Qualification Process for Drug Development Tools
223803.11.2010EMA Discussion Paper on intravenous Products with poorly resolvable APIs
223228.10.2010WHO starts Pilot Programme for pre-qualifying APIs
223028.10.2010FDA provides Tips for Inspections
222628.10.2010FDA: New Guidance on Investigational New Drug Applications (INDs)
222020.10.2010EMA Management Board adopts new Policies
221320.10.2010FDA Inspection Reports: What is what?
222213.10.2010GMP and Quality Regulation in Japan
221713.10.2010The APIC revises the "ICH Q 7 How to do" Document
221113.10.2010Clinical Trials: FDA publishes final Rules for Safety Reporting
220906.10.2010New Biological Applications (BLA) - The Future of Pharmaceuticals
220706.10.2010Variations Regulation: how to classify special Changes
220606.10.2010Will FDA join PIC/S this Year?
220329.09.2010ICH Q10: What European Inspectorates will look for
220129.09.2010Non-Investigational Medicinal Products in CTAs: Results published of Public Consultation
220023.09.2010Rx-360 receives Approval from FTC and exhibits at CPhI Tradeshow
219423.09.2010MHRA requires active Maintainance of API Manufacturing Sites
218523.09.2010WHO Publishes Guidelines on the Use of Quality Risk Management
218323.09.2010Outcome of EMA Workshop on Clinical Trials and Global Medicines Development
216715.09.2010English Supervisory Authority MHRA Publishes Answers to FAQs on Risk Management
216115.09.2010EMA Reflection Paper on the Use of Electronic Data in Clinical Trials published
215215.09.2010The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way
208215.09.2010Clinical Trials in India - Current Developments
217908.09.2010Important change to the planned production of EudraCT Version 8.0 and the Clinical Trials Application Form
217708.09.2010WHO proposes new Sections for Guideline on Quality Assurance Topics
216308.09.2010Revision of USP <1235> Vaccines for Human Use - General Considerations
213708.09.2010FDA Fosters the Development of Better Medical Devices
217401.09.2010FDA revises Guidance Document on Pre-Approval Inspections
215601.09.2010New WHO Draft on the Manufacture of Sterile Medicinal Products
215401.09.2010New Toxicological Data on Isopropylbenzene Trigger its Categorisation as Class 2 Solvent
212501.09.2010Inspection of Biological Drug Products
215925.08.2010FDA publishes Q&As on Drug Recalls
215725.08.2010EMA and US FDA seek potential Candidates for joint GMP Inspection Programme
215125.08.2010Impurities and Setting Specifications - the EMA Publishes Harmonised Policies on Its Q&A Page
214518.08.2010Specific Requirements on Plastic Packaging Materials for APIs and Solid Dosage Forms?
214218.08.2010EudraCT Version 8.0 and new CTA Application Form will go into production soon
212018.08.2010What Is Wrong with APIs from China and India?
209918.08.2010Free Access to WHO GMP Inspection Reports
214712.08.2010Shared Audit at Pfizer's Manufacturing Site in the US
213212.08.2010European Commission Will Revise IVD Guideline
213012.08.2010Stability of Pharmaceutical Bulk Products - Which Data Are Dossier-Relevant?
211412.08.2010Changes in the Pharmacopoeia: how to submit a Variation?
209712.08.2010WHO revises Good Distribution Practices for Pharmaceutical Products
213804.08.2010FDA includes Remanufacturers of Medical Single-Use Devices in cGMP Rules
213304.08.2010MHRA publishes new Enforcement Strategy
212304.08.2010New draft of ISO 14644-9 - Classification of Surface Cleanlinesss
212628.07.2010How to Facilitate the Transition between Process Validation and Continuous Verification
211128.07.2010FDA Proposes to Publish More Information about Inspection Planning and Outcomes
210128.07.2010WHO publishes new Guideline for the preparation of a CRO Master File
210920.07.2010FDA Videos on Quality by Design Initiatives
210820.07.2010WHO Adopts GMP for APIs from the ICH Q7 Guideline - additional explanations added
210420.07.2010FDA publishes Draft Guidance on CMC Postapproval Changes (Annual Reports)
212114.07.2010New Questions in the RMM Discussion Forum
211914.07.2010FDA Plans New Part 11 Inspections
211714.07.2010Revision of EP chapter 5.1.6. Alternative Methods for Control of Microbiological Quality
208914.07.2010WHO Publishes Guide on the Handling of Highly-Active Substances
208514.07.2010Guidance for the use of UK Stand Alone Contract Laboratories published
207714.07.2010USP 1050 Viral Safety of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - proposed Revision
207214.07.2010Authority Statement on Validation in Pharmaceutical Development
209407.07.2010Revised Annex 13 on Investigational Medicinal Products (IMP) coming into operation
209107.07.2010Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7
207407.07.2010The New Role of PAT as an Integral Part of QbD
206707.07.2010EMA Draft Guideline open for Comments: Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses in Cell Culture
208630.06.2010FDA Plans to Revise cGMP Guide Focussing on Outsourcing and Raw Materials
208030.06.2010FDA Publishes Draft Guidance on Third-Party Audits of Medical Device Manufacturers
206930.06.2010News on Turkey's Tracking & Tracing System
206530.06.2010Clinical Trials: new Document for public Consultation
206430.06.2010New Documents by CMD(h) on "Unforeseen Variations"
207023.06.2010Comprehensive Study about Verification of GMP Compliance at API Manufacturers published by DMA
204823.06.2010Clinical Trials: FDA proposes new Data Falsification Rule
205716.06.2010European Commission Decides to Establish a European Database for Medical Devices (Eudamed)
205616.06.2010FDA Guideline to Reduce the Risk of Transmission of CJD and vCJD by Blood and Blood Products
205116.06.2010Regulation amending the REACH Annexes relevant for SDS (Safety Data Sheet)
204516.06.2010Revised Q&A Document available in EudraLex Volume 10 - Clinical Trials
204309.06.2010EMA publishes Reflection Paper on ethical and GCP Aspects of Clinical Trials conducted in third Countries
204109.06.2010USP seeks Submission of Proposals for Monograph Modernization
203802.06.2010New Best Practice Guides for the Submission and Processing of Variations published
203402.06.2010Outcome of the survey to the new EU GMP-Guideline Chapter 1
203202.06.2010Discussion of the EU Pharma Package in the European Council of Ministers
202827.05.2010New Template for Drug API Quality Agreements
202727.05.2010FDA Inspections in China - Consequences from the Heparin Case
202527.05.2010Warning Letter Analysis for Process Validation
201819.05.2010Database "QPSHARE" for Planning Joint Audits Already Used Intensively
201619.05.2010Why Are There More and More Serious GMP Deficiencies on the Basis of Inspections?
201419.05.2010Revised EMA Paper Specifies Requirements on Preparation, Conduct and Follow-Up of Official Inspections
200519.05.2010Webinar with FDA's John Murray on Software Validation in the Field of Medical Devices
201112.05.2010FDA answers questions to ICH Q8, Q9, and Q10
200712.05.2010EFPIA Publishes Results of the Track & Trace Project
199712.05.2010Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC
200205.05.2010EDQM initiates survey about the production of Water for Injection (WFI)
199505.05.2010Further CEPs suspended and withdrawn by EDQM
198905.05.2010Shared Audits: How Can You Find Partners in Order to Share Audit Costs?
198605.05.2010FDA Finalises Guidance on the Standardisation of the Numerical Identification for Medicinal Products
198405.05.2010FAQs on the EMA-FDA GCP Initiative published
199929.04.2010Public Consultation on Annex 2 started
197729.04.2010New FDA - NIH Initiative on a Formulations Framework for paediatric Drugs
197229.04.2010EMA publishes Draft Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
196729.04.2010Tracking & Tracing: EU decides on Amendments to Guidelines
195129.04.2010EMA revises its Process Validation Guidelines
198221.04.2010New EMA Guidelines in Force for GMP Infringements by Manufacturers of Active Ingredients and CEP Revocation
197521.04.2010Will there soon be obligatory GMP Regulations for Excipients?
193821.04.2010Germany's Preparations for the Traceability of Medicines
192621.04.2010New EU Requirements in the Validation Process in the Form of a Revision of Section 1 of the EC GMP Guidelines?
197914.04.2010Survey: Revision of Chapter 1 of the EU GMP Guide
196914.04.2010European Compliance Academy (ECA) established as Foundation
196814.04.2010Counterfeit Medicines: EFPIA Position Paper on the European Commission's Draft
194814.04.2010New EMA Report on the 2008 Sampling and Test Programme
194514.04.2010FDA Guidance for Submission of Documentation in Applications for Parametric Release
196208.04.2010Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA)
196008.04.2010Interesting Pilot Project for safe Trade Routes introduced
194208.04.2010Real Time Release Testing (Parametric Release) - EMA publishes new Guideline Draft open for Consultation
195331.03.2010EMA Guideline for Stability Testing for Applications for Variations in revision
192831.03.2010MHRA Consultation Procedure for Strengthening Secure Supply Chains
191731.03.2010Deviations and CAPA most frequent observations in FDA inspections
187531.03.2010Microbiological Control of Herbal Drugs
196124.03.2010European QP Association Releases Database "QPSHARE"
195024.03.2010Final Annex 13 on Investigational Medicinal Products Published
193924.03.2010FDA publishes finalized Guidance for Characterization and Qualification of Cell Substrates and Other Biological Materials
191924.03.2010Central Anti-Counterfeit Laboratories - a Strategy to fight against Counterfeit Medicines
194417.03.2010HPLC in FDA Warning Letters 2009
194117.03.2010Q-and-A List by EMA on the Centralised Procedure Extended
193217.03.2010Memorandum of Understanding (MoU) signed between PIC/S and Russia
192517.03.2010Which Role Does the Rx-360 Consortium Play in the Fight against Counterfeit Medicines?
192208.03.2010FDA Director of Pediatric International Program to speak at ECA Development Conference
190708.03.2010EMA's Inspectors Working Group Publishes Work Plan 2010
190308.03.2010Recent Statement by FDA on Process Validation - 3-Batch Validation Obsolete?
188508.03.2010Current FDA Procedures for Counterfeit Medicines
192903.03.2010FDA to speak at ECA Development Conference on Quality by Design
191503.03.2010FDA announces new Programme for a more efficient Inspection of Imports
189203.03.2010EMA publishes "Draft Guideline on Validation of bioanalytical Methods"
187603.03.2010Review of Supplement 6.8 European Pharmacopeia 6th Edition
190524.02.2010European Medicines Agency develops European Network of Paediatric Research
189124.02.2010Genotoxicity Research - New HMPC Guideline for Herbal Medicinal Products
185424.02.2010Inspection Results of the MHRA Published
184924.02.2010PQR and Management Review: Increasing Importance
190817.02.2010Q&A Document on Variations Regulation published
189617.02.2010European QP Association To Release the Database "QPSHARE" Soon
188917.02.2010Warning Letters Report 2009 - Increasing number of Warning Letters
188317.02.2010FDA Guidance on "Mechanical Calibration of Dissolution Apparatus" Passed
187817.02.2010EDQM announces new System for Revision/Renewal of CEP Certificates
187311.02.2010Recall of USP 33-NF 28!
186611.02.2010EU Commission finally issues Guidance on new Variations Rules
185611.02.2010Inspection Results on Investigational Medicinal Products Published
185011.02.2010EMA Update on Dedicated Facilities
181811.02.2010Overview of new and withdrawn FDA Guidances 2009
186403.02.2010EC Commission Publishes Draft on the Creation of a Site Master File
185203.02.2010New CAPA Guidance Published
184503.02.2010Current Status of the Counterfeit Directive in the EU Parliament
181303.02.2010Recent Changes Concerning the USP Dissolution Performance Verification Test
186127.01.2010PIC/S publishes Example of Methodology for the Implementation of Quality Risk Management (QRM) in pharmaceutical Industry
184227.01.2010Draft for the Revision of EU GMP Guide Chapter 2 "Personnel"
183827.01.2010European Commission Publishes Proposal for Part 3 to the EC GMP Guide
183727.01.2010FDA Publishes Statement on the Frequency of Media Fills
182227.01.2010Discussion about Safety Features/2D Datamatrix Code Continues
185720.01.2010The APIC Publishes Templates for Quality Agreements
184420.01.2010European Commission Publishes Proposal for Part 3 to the EC GMP Guide
183520.01.2010EDQM Announces the Suspension of Further CEPs
184013.01.2010Revision of EU GMP Guide Chapter 1 Published
182513.01.2010When Will the New Variations Regulation Come into Operation?
182313.01.2010Riboflavin Test for Cleaning Validation - Standardisation regarding Information Sheet of VDMA
181613.01.2010Interpretation of the New Annex 1 to the EC GMP Guide by PIC/S
182116.12.2009Important Changes at EMEA
181016.12.2009New FDA Guidance on Residual Solvents
180516.12.2009Interesting Addition to the Q&As on ICH Q8, Q9 and Q10
180409.12.2009Annexes to ICH Q4B Guideline Reach Next Step
180309.12.2009FDA adapts ICH Q8 (R2) Pharmaceutical Development as Guidance for Industry
179009.12.2009New FDA Guidance on Impurities in APIs for Generics
180102.12.2009EMEA: New Application Form for Scientific Advice
178802.12.2009New White Paper by USP
178202.12.2009Risk Posed by Counterfeit Personal Protective Equipment
179825.11.2009Modern Aspects of Equipment Qualification
179325.11.2009EMEA Reflection Paper on the Extrapolation of Results from Clinical Studies published
178518.11.2009New Report on EU/EMEA and FDA Collaboration published
178418.11.2009EMEA publishes Concept Paper on the Revision of the Guidance on Radiopharmaceuticals based Monoclonal Antibodies
178018.11.2009The New Variations System - what is the current situation?
175411.11.2009Method Transfer - USP Plans New General Chapter
172211.11.2009Three years of the EU Paediatric Regulation - what happened?
177404.11.2009FDA and EU Commission inform about Collaboration on Inspections
177004.11.2009Chapter 7 of EC GMP Guide to be revised
176728.10.2009FDA publishes Guidance for Industry regarding Risk Evaluation and Mitigation
175128.10.2009Deputy Director Europe/US FDA will speak at QP Forum
174928.10.2009FDA published final Guidance on End-of-Phase 2A Meetings
174428.10.2009Extension of the FDA Pilot Programme for Biotechnological Products
174721.10.2009FDA Warning Letter: New Procedure established
174221.10.2009Public Assessment of the Clinical Trials Directive
174015.10.2009Medical Devices Warning Letter Report 2009 - CAPA Still First
173715.10.2009ICH Q8 Pharmaceutical Development Completed
173807.10.2009Webcasts for FDA Transparency Task Force to Public Meetings available
173507.10.2009FDA Issues Draft on cGMP Regulations for "Combination Products"
173007.10.2009USP Suggests additional Testing for Visible Particles in Parenterals
173230.09.2009Sample Documents for Participants in the Seminar Validation of Analytical Test Procedures
172830.09.2009Personal Liability of the Qualified Person and Possibilities for Insurance
172123.09.2009Dutch Medicines Authority Takes Measures after CEP Suspension by EDQM
167423.09.2009Pharmaceutical Aspects of Product Information - EMEA publishes Concept Paper on a Guideline Revision
165223.09.2009Supplier Qualification more and more in the Focus of Authorities
171916.09.2009Quality Agreements for Excipients - Indispensable for a Transparent Supply Chain
169516.09.2009CBER: Vaccines, Blood and Biologics - Exception or alternative Procedures
168016.09.2009EMEA publishes Guideline on Investigation of Medicinal Products in the Term and Preterm Neonate
165716.09.2009USP <1235> Vaccines for human Use - general Considerations
169809.09.2009New EMEA Q&As on ICH Q8, Q9 and Q10
169709.09.2009FDA prepared to act more aggressively
166509.09.2009EMEA Draft Guideline on Quality, Non Clinical and Clincal Aspects of Live Recombinant Viral vectored Vaccines
170702.09.2009EudraGMP 2.0 gives public access to information about GMP certificates
170302.09.2009EFPIA Criticises Increasing Number of Inspections
169202.09.2009Quality by Design (QbD) - Contribution by Excipients Manufacturers
167702.09.2009FAQ: Which Test for Evaluation of Activity of chemical Disinfections are relevant for the Pharmaceutical Industry?
170226.08.2009Joint GCP Initiative Launched by EMEA and FDA
165626.08.2009ICH Q4B Annex 8 now in Step4
165426.08.2009FDA limits Timeframe for Responding to a 483
169019.08.2009New ICH Q4B Documents issued for Europe
168619.08.2009Internet presentations regarding Cleaning Validation
166619.08.2009FDA: cGMP expectations in Pharmaceutical Development
163619.08.2009Update of the PIC/S Recommendation PI 007-4 Validation of Aseptic Processes
169412.08.2009EMEA Database on GMP Inspections now publicly available (EudraGMP)
168712.08.2009Revised Q&A Document available in EudraLex Volume 10 - Clinical Trials
166212.08.2009ICH Topic E16 Genomic Biomarkers Related to Drug Response - Deadline for Comments in September 2009
164212.08.2009FDA Opens 3 Offices in Europe
167605.08.2009The New FDA Guideline on Impurities in Generics
167205.08.2009European Commission Publishes Comments on the Variations Guidelines
164905.08.2009Danish Medicines Agency - Questions and Answers on GMP for APIs
164705.08.2009FDA Publishes Guideline to Fight Counterfeit Medicines
166829.07.2009API�s from Asia at Risk - Further CEP�s Suspended
163729.07.2009FDA publishes "The Enforcement Story" Report
166122.07.2009Official Measures to Protect against Low-Quality APIs and Investigational Medicinal Products Co-ordinated throughout Europe
165922.07.2009New FDA Draft Guidance on Postmarketing Studies and Clinical Trials
163922.07.2009Danish Medicines Agency launches Project on Monitoring of GMP Compliance of APIs
163415.07.2009EDQM issues Guidelines for OMCL Network
162215.07.2009Public Consultation on Draft Revision 3 of detailed Guidance for the Request for Authorisation of a Clinical Trial
162708.07.2009FDA Publishes New Q-and-A on cGMP for Penicillin Drugs
161908.07.2009FDA adopts Pharmaceutical Development Guidance
161608.07.2009FDA, TGA and EDQM establish Confidentiality Agreements
162901.07.2009Further CEPs from Chinese and Indian Manufacturers suspended or withdrawn
162401.07.2009EMEA Draft Transparency Policy published for Consultation
160301.07.2009QPs implemented in new Canadian GMP Regulations?
161123.06.2009GMP for Excipients - New Decision of the EU Commission may lead to Misinterpretation
160123.06.2009Series of QP related Q&As published
160817.06.2009New Guidance for Coordination of GCP Inspections published
160617.06.2009Quo vadis GMP?
159217.06.2009EMEA: Guideline on Missing Data in Confirmatory Clinical Trials
159710.06.2009FDA forms Transparency Task Force
157310.06.2009Current Ph.Eur. Requirements on Pharmaceutical Water
155110.06.2009New Guidance: Formal Meetings Between the FDA and Sponsors or Applicants
159503.06.2009EMEA publishes Question/Answers on Endotoxin Testing and Sterility Testing
158903.06.2009EMEA issues new Draft regarding NIRS
156903.06.2009Commission Directive regarding Advanced Therapy Medicinal Products approved
158727.05.2009University of Mannheim initiates Survey on Risks in the Supply Chain
158427.05.2009Pharmaceutical Development: New Challenges through ICH Q8 Annex
157827.05.2009FDA requests a 19 Percent Budget Raise
158020.05.2009Overview of New and Withdrawn FDA Guidances
156820.05.2009EMEA publishes new Draft of "Guideline on Plasma derived Medicinal Products"
157614.05.2009EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing
157414.05.2009ICH Publishes Questions-and-Answers Document on Q8, Q9 and Q10
156507.05.2009Two Recent FDA Warning Letters to Chinese API Manufacturers Reveal Enormous Risks in the Procurement of Starting Materials
138507.05.2009EMEA publishes new Q and As on PAT
155929.04.2009EDQM suspends five CEPs after inspecting Chinese Manufacturer Sites
155329.04.2009New EMEA Concept Paper on the Revision of the EU Guideline Good Distribution Practices (GDP)
155722.04.2009EDQM Guideline on Suspension or Cancellation of a CEP
155522.04.2009Updated Categories of Variations in the New Variations Regulation
153122.04.2009Batch Record Review in the Focus of Inspection Authorities
154608.04.2009Validation Findings in FDA Warning Letters 2008
154008.04.2009EMEA Plans on Revising EC GMP Guide to Implement ICH Q10
152308.04.2009Validation of USP Methods - Incorporation of ISO Terms!
154301.04.2009FDA issues new Draft Guidance regarding "Genotoxic and Carcinogenic Impurities in Drug Substances and Products"
152101.04.2009FDA Guideline on Drug Stability Studies of Animal Drugs
149801.04.2009PIC/S publishes new Aide-Memoire on the Inspection of Manufacturers of Active Pharmaceutical Ingredients
153625.03.2009Implementation of the Variations Regulation: 2 Public Consultation Papers published
153325.03.2009ECA's 10th Annual Review (2008)
152525.03.2009Out-of-Specification Results and Failure Investigations in current FDA Warning Letters
149625.03.2009CDER Update - FDA Recalls
149325.03.2009New PIC/S Guide for the Inspection of Packaging Processes and Facilities
153518.03.2009GMP Guideline Manager with new web-based software - free of charge for ECA Members
150818.03.2009ICH Publishes Contact Address for Submitting Questions on Q8, Q9 and Q10
149018.03.2009EMEA publishes Questions and Answers on the Quality of IMPs
137418.03.2009European Recommendations on Dissolution Testing
152711.03.2009New USP General Chapter on Residual Solvents - Implementation by the FDA?
151311.03.2009Results of the Survey: "How Will You React to the New FDA Guidance on Process Validation?"
150111.03.2009Annex to ICH Q8 Pharmaceutical Development reached Step 5
146511.03.2009FDA Guidance on Standardised Identification for Medicinal Products
150610.03.2009Update of the PIC/S Recommendation on the Validation of Aseptic Processes
150310.03.2009EMEA publishes Questions and answers on the preparation of applications for a PIP and/or waiver
148610.03.2009EMEA publishes Strategy Paper on 'Acceptance of Clinical Trials conducted in third Countries'
141110.03.2009New FDA Guidance for shared Manufacturing of Biologics
148825.02.2009Guidelines concerning Paediatric Clinical Trials and EudraCT published
148125.02.2009EMEA Publishes New Version of the Reflection Paper on QP Discretion
148025.02.2009API Focused MHRA Inspections at Dosage Form Manufacturers
136325.02.2009Medical Devices Warning Letters Report 2008 - CAPA 1st
148518.02.2009FDA Globalization Act: Far-reaching Consequences for the Pharmaceutical Industry
147618.02.2009Warning Letters Report 2008 - Frequent Deficiencies in Deviation Reviews
147318.02.2009Compliance Problems through Acetonitrile Shortage?
147118.02.2009Monoclonal Antibodies - Comments received on the Guidelines
144511.02.2009Annex 8 of ICHQ4B in Step3
143511.02.2009Dissolution Test - New ICH-/EMEA-Document
146304.02.2009WHO Guide regarding GMP-Training Requirements
146104.02.2009Acceptance of Third-Party Audits - Will There Be an Accreditation?
144104.02.2009List of new, withdrawn and revised FDA guidances published
139304.02.2009Pediatric Drug Development: FDA Requirements
145928.01.2009New FDA Guidelines for an Increased Safety of Medicinal Products and Foodstuffs
145228.01.2009FDA Starts Secure Supply Chain Pilot Programme
142628.01.2009Track and Trace - New EU Requirements on the Packaging of Medicinal Products
128028.01.2009The New APIC Quick Guide for Procuring GMP-Compliant APIs
145021.01.2009Which Changes Have to Be Made to the Validation Strategy Due to the New FDA Process Validation Guide?
142921.01.2009Result of the Public Consultation on the Revision of the PIP Guideline Published
140821.01.2009Pharmaceutical Development: EMEA QWP plans for 2009
144915.01.2009EU Commission and EFPIA Activities against Counterfeit Medicine
143815.01.2009New ICH Q4B Annexes
142715.01.2009European Variations Regulation Published
143008.01.2009Annex to ICH Q8 Pharmaceutical Development reached Step 4
141708.01.2009FDA Opens Offices in China and Tightens Inspections Also in Europe
142117.12.2008European Commission Publishes Package of Measures against Counterfeit Medicines
141517.12.2008ISO 9001 - New Version Published
141310.12.2008EMEA Plans Amended Guideline on Parametric Release
138610.12.2008Center for Biologics Evaluation and Research (CBER) - FY 2007 Annual Report
136710.12.2008Procedures and Guidances for GCP Inspections
141003.12.2008Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA)
139503.12.2008FDA reported Fatalities following Blood Collection and Transfusion
139003.12.2008FDA Pushing Ahead with Quality by Design (QbD) Developments
140226.11.2008FDA`s New Process Validation Guidance - A detailed analysis
139726.11.2008Implementation of the Paediatric Regulation: new Commission Guideline
125526.11.2008EMEA publishes Drafts regarding the ICH Topic Q4B
139920.11.2008FDA Publishes New Question and Answer Section on cGMP Compliance
137220.11.2008Revised Annex 7 to the EC GMP Guide: Manufacture of Herbal Medicinal Products
132320.11.2008MHRA publishes Good Pharmacovigilance Practice Guide
138212.11.2008New Questions and Answers published by EMEA
127312.11.2008New FDA Approach for Feedback on Applications for a Marketing Authorisation (NDA/ ANDA)
134105.11.2008Variations Regulation: ENVI Committee of European Parliament adopts Draft Report on Variations
132005.11.2008News from the GCP Inspectors Working Group
125905.11.2008EDQM optimises Evaluation Process of CEP Applications
138029.10.2008Change of Consultation Period for the Revision of Annex 13
126929.10.2008FDA Expectations regarding Facilities for Sampling Packaging Materials
126029.10.2008Further Documents regarding Paediatric Regulation published
136522.10.2008Consequences of the new ICH Guideline Q 10 (Pharmaceutical Quality Systems)
136222.10.2008FDA Changes Medical Devices CGMP Rules
135422.10.2008WHO Recommendations on Anti-Counterfeit Technologies
136015.10.2008New Annex 3 "Manufacture of Radiopharmaceuticals" Comes into Operation on 1 March 2009
133615.10.2008EMEA publishes Guideline on Training and Qualification of GMP Inspectors
136108.10.2008FDA Changes CGMP Rules (21 CFR 210/211)
135608.10.2008Counterfeit Drugs - Questions-and-Answers Paper from FDA
134508.10.2008What Does a GMP-Compliant Certificate for Excipients Look Like? - New USP General Chapter <1080>
133324.09.2008Several GCP Inspection Procedures published
128824.09.2008REACH - Possible Consequences for Validation of Disinfectants
130018.09.2008Guideline on Investigation of Bioequivalence released for Public Consultation
128918.09.2008New FDA Plans possibly impact Supply Chain and related Import Activities
131110.09.2008USP Chapter <645> 'Water Conductivity' Revised
128110.09.2008FDA Submission Requirements on Parametric Release for End-Sterilised Products
131604.09.2008Current Aspects of Cleaning Validation in the Literature
129604.09.2008Stricter Requirements for the Transport of Medicinal Products at Room Temperature
130927.08.2008EMEA Drafts Pilot Project for the Rationalisation of GMP Inspections
128327.08.2008New Draft for FDA Globalisation Act Calls for Quality Risk Management Plans
129420.08.2008Quality by Design for Biotechnological Products: New FDA Pilot Programme
126720.08.2008EMEA Evaluates Use of GMP-Compliant API Production
128413.08.2008Eustite - Inspector Trainig Courses started succsessfully
127613.08.2008Impurities in Antibiotics: EMEA Issues New Concept Paper
124906.08.2008Current Interpretation of the FDA Requirements on Sampling
124806.08.2008EDQM publishes Update on Heparin Monograph and Policy Paper for dealing with potentially genotoxic Impurities
124530.07.2008Joint Inspections and Further Cooperation between EMEA and FDA Announced
124430.07.2008FDA Publishes New Guideline on the Manufacture of Phase 1 Investigational Medicinal Products
124023.07.2008OECD: Biotechnology Update of the Internal Co-ordination Group of Biotechnology
123923.07.2008The FDA Clinical Investigator Inspection List
123416.07.2008EDQM publishes new Requirements for the CEP Certification Procedure
123516.07.2008European Commission publishes new Variations Regulation Draft
123109.07.2008U.S. Department requests higher Budget for FDA
123009.07.2008EMEA Updates Inspection Manual with Reference to ICH Q9
122702.07.2008Draft Guideline on Safety and Efficacy Follow-Up-Risk Management of Advanced Therapy Medicinal Products
122602.07.2008ICH Guideline Q10 "Pharmaceutical Quality System" Finalised
122325.06.2008FDA publishes draft of Biological Product Deviation Reports Summary
122225.06.2008Will the Quality by Design Approach Increase Costs and Resources?
121918.06.2008Visions of CBER for Vaccine Manufacturing
121818.06.2008New Amendments to Eudralex Volume 10
121411.06.2008European QP Association Initiates Shared Audit Database
121311.06.2008Medicine Counterfeits: EU Commission publishes Comments from Associations
121004.06.2008Consequences of the Guideline 98/8/EG and the Biocide Act for the pharmaceutical industry
120904.06.2008European Commission, EMEA and FDA decide to intensify cooperation
120629.05.2008Training Slides on Validation from the WHO
120529.05.2008GHTF Publishes Auditing Guideline
120221.05.2008EDQM publishes "Guide to the Preparation, Use and Quality Assurance of Blood Components"
120121.05.2008New FDA Plans Intend to Ensure Drug Safety for Imported Products
119714.05.2008Risk-based Inspection Programme - a Model for Future Inspections?
119614.05.2008New Draft of Inspection Guideline on Tissue and Cell Procurement
119514.05.2008Revised Chapter 4 of the EU Guideline to GMP Released for Public Consultation
119107.05.2008Adoption of the Commission Proposal on Variations (co-decision part)
119007.05.2008PIC/S Publishes Guideline for GMP in Healthcare Establishments
118907.05.2008Will the FDA Continue Its Initiative "cGMPs for the 21st Century"?
118530.04.2008European Compliance Academy (ECA) Initiates New Working Group
118430.04.2008EU Plans Extension of GMP Guide for APIs to Quality Risk Management
118330.04.2008ICH Q11 - A New Guideline for the Development of APIs Is Being Created
117923.04.2008Draft Annex 13 Released: European Commission Asks for Comments
117823.04.2008EMEA Issues Statement on WFI Preparation through Reverse Osmosis
117723.04.2008New FDA Guidance on Dissolution Testing: No Calibrator Tablets!
117216.04.2008EMEA Publishes Q-and-As on Genotoxic Impurities
117116.04.2008EU Publishes New Version of EU GMP Guide Annex 11 "Computerised Systems"
117016.04.2008FDA Reacts to Recent Problem Cases and Establishes
GMP Inspection Office in China
116709.04.2008FDA Withdraws Changes to the cGMP Guide (21 CFR 210/211)
116609.04.2008Consultation on the Revised Annexes 1, 2 and 3
on the Clinical Trial Application Form
114709.04.2008European Commission Plans Far-Reaching Changes to GMP and GDP in the Fight against Counterfeit Medicines
116202.04.2008Chinese Regulatory Agency: Drug and API Importers are Responsible for Supply Quality
116102.04.2008Deviations and Failure Investigation - CAPA in the Light of FDA Inspections
115826.03.2008USP General Chapter <1058> Analytical Instrument Qualification Comes into Force on 1 August 2008
115626.03.2008FDA Confirms Use of "Container Closure System Integrity Testing" instead of "Sterility Testing" in Stability Testing
115219.03.2008EMEA Releases Concept Paper on a Guideline on Documentation Concerning Biological IMPs
115119.03.2008FDA Provides Certifications to Accompany Applications or Submissions on Website
114619.03.2008New Version 10.0 of GMP Guideline Manager Software Released - Free of Charge for ECA Members
114412.03.2008Annual Review 2007
114312.03.2008GMP for Excipients - The USP General Information Chapter <1078> under Revision
114212.03.2008CDER Guidance Agenda Published
113805.03.2008FDA Requests Nearly $2.4 Billion as Part of the President's Fiscal Year (FY) 2009 Budget
113705.03.2008Handling of OOS Results � Still an Important Issue in FDA Inspections
113605.03.2008Warning Letters Report 2007
Frequent Deficiencies in Quality Control Labs and in the Clearing of Deviations in Production
113504.03.200810th APIC Conference on Active Pharmaceutical Ingredients
113128.02.2008FDA Approval for Parenteral Products in Plastic Immediate Containers
113028.02.2008FDA Guidance on Alternative Sterility Testing
112928.02.2008New EMEA Paper on Markers for Herbal Medicinal Products
112621.02.2008EMEA Issues Statement on Status of Revision of GMP Guide Concerning "Dedicated Facilities"
112521.02.2008EU Publishes Changes to Chapter 1 EC GMP Guide and Annex 20
112421.02.2008New Version of Annex 1 to the EC GMP Guide on Sterile Manufacture Published
111913.02.2008List of New, Withdrawn and Revised FDA Guidances Published
111813.02.2008EMEA's Piotr Krauze Confirmed to speak at ECA Good Development Conference
111713.02.2008Eudralex Volume 10 Updated
111306.02.2008Outcome of the Public Consultation of the Review of the Variations Regulations (Comitology Part) Published
111206.02.2008Expert Team of German Medicines Manufacturers' Association Develops Quality System Manual
111106.02.2008EU Council Adopts EFPIA Joint Technology Initiative on Innovative Medicines
110830.01.2008FDA Foreign Inspection Programme under Review
110730.01.2008Medical Devices Warning Letters Report 2007 - Process Validation Again among the Top 5
110424.01.2008European QP Association Plans on Launching Interest Group for Advanced Therapies
110324.01.2008FDA Reacts to Report Accusing the Authority of Serious Deficiencies
110016.01.2008Amendment to Chapter 5 of the GMP Guide ("Qualification of Suppliers") Expected in Early 2008
109916.01.2008Recognition of Compendial Methods -
109619.12.2007Identification and Classification of Deficiencies in Glass Packaging Materials
109519.12.2007New GMP-Guide on Qualification Approved by the ASTM
109113.12.2007ICH Publishes Annex to ICH Q8
109013.12.2007FDA Modifies cGMP Guide - New Text Published
108705.12.2007FDA Inspections at Biological Drugs Sites
108605.12.2007The FDA Does Recognise Alternative Compendia (BP/EP/JP) After All
108328.11.2007Complaint Handling and Recalls in the Focus of Regulatory Inspections and Enforcement
108228.11.2007New Proposals for Analytical Balances and Quality-Relevant Weighing Processes in the American Pharmacopoeia
107921.11.2007Classification of GMP-Observations in the Various Inspectorates
107821.11.2007EMEA Publishes Draft on Assessment of the Quality of Medicinal Products Containing Existing/Known Active Substances
107415.11.2007European Companies and QPPVs in the Focus of U.K. Pharmacovigilance Inspections
107315.11.2007Implementation of Modern GMP Aspects: Revision of the Annex 2 of the EC GMP Guide as an Example
107215.11.2007New EMEA Guideline Draft on Stability Testing with Modified Testing Conditions
106907.11.2007FDA Estimates Effort for Implementing Requirements for Medical Devices
106807.11.2007EU Commission Publishes Draft of New Variation Regulation
106402.11.2007Input for ECA's RMM Best Practice Guide Chapter from Leading Industry Expert
106302.11.2007EU Commission and EMEA Plan Extensive Further Development in the GMP Environment
106025.10.2007Clinical Trials in India: recent developments
105925.10.2007FDA Plans Changes to the cGMP Guide (21 CFR 211)
105822.10.2007Swiss Biotech Association and IFAPP in co-operation with the ECA
105722.10.2007New GAMP® Good Practice Guide "Electronic Data Archiving"
105522.10.2007News from the FDA Regarding Inspections, GMP Deficiencies and Recalls
105009.10.2007How to Overcome Problems during Validation of an Alternative Microbiological Test System?
104909.10.2007European Commission Releases New GMP Guide Annex 2 for Biologics for Consultation
104809.10.2007EMEA Publishes New HMPC Guideline on Combination Herbal Medicinal Products
104404.10.2007India's Central Drug Authority Gets More Power to Control Clinical Trials
104304.10.2007Outsourcing: What Has to Be Taken into Account from a GMP Perspective?
104204.10.2007Update of USP General Chapter <1010> "Analytical Data - Interpretation and Treatment" Suggested
103826.09.2007EMEA Publishes Updated Questions & Answers Guidance on Variations
103726.09.2007USP Chapter <643> TOC and <645> Conductivity in Revision
103626.09.2007UK Pharmaceutical Industry Association Revises Guidelines for Phase I Trials
103219.09.2007FDA CDER Publishes Facts-and-Figures Document
103119.09.2007FDA Publishes Guideline for Eligibility Determination for Donors of Human Cells and Tissues
103019.09.2007PIC/S Publishes New Version of GMP Guide
102712.09.2007Current EMEA Statements regarding the Introduction of the Harmonised Test Methods in Microbiology
102612.09.2007Raman Spectroscopy in the USP
102205.09.2007EDQM Issues Q&A Documents on Harmonised Microbiological Test Procedures
102105.09.2007ISPE Publishes White Paper on "Dedicated Facilities"
101729.08.2007Harmonisation of EMEA GMP/GDP and GCP Inspectors Groups
101629.08.2007Revision of the EU Variations Regulations
101222.08.2007EU GMP Guide Annex 6 "Manufacture of Medicinal Gases" Draft Revision published for Public Consultation
101122.08.2007EMEA Publishes Guideline on Strategies to Identify and Mitigate Risks in first-in-human Clinical Trials with IMPs
100716.08.2007EMEA Publishes Q&A Document on the ASMF Procedure and on Specifications of Residual Solvents
100616.08.2007USP Publishes Revised General Chapter on NIR and Takes Account of the Increased Use of NIR in PAT
100308.08.2007Free Webcast from the Chairman of the European QP Association Available
100208.08.2007MicroSeq Chapter of ECA's RMM Good Practice Guide published for discussion
100108.08.2007ISO Standard 15378 with GMP Requirements to Manufacturers of Primary Packaging Materials Adopted as EN Standard
99701.08.2007Free Webcast with Chairman of ECA's Working Group on
Rapid Microbiological Methods Dr Robert Johnson
99601.08.2007EMEA Provides Guidance for
99501.08.2007USP General Chapter <1226> Comes into Force on 1 December 2007
99226.07.2007Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA)
99126.07.2007MHRA Publishes Pharmacovigilance Inspection Metrics Reports for 2006
99026.07.2007FDA's CBER Updates Q&A List Concerning the Current Good Tissue Practice (CGTP) Final Rule
98718.07.2007New Guidance Published in Eudralex Volume 10 - Clinical Trials
98618.07.2007FDA's Office CBER Publishes Q&As on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
98311.07.2007EMEA Holds Workshop on First-in-Man Clinical Trials Draft Guideline
98211.07.2007FDA Representatives Conduct Q&A Session on OOS Results
97904.07.2007Harmonisation of Pharmaceutical Water Requirements in Pharmacopoeias Continues
97804.07.2007FDA Announces Expansion of Cooperation with EC and EMEA
97528.06.2007EMEA Facilitates Proposal to Establish a Harmonised Format for IMP Batch Release Certification
97428.06.2007EMEA Issues SOP on Coordination of Pre-Approval GxP Inspections
97120.06.2007TOC in the Japanese Pharmacopoeia
97020.06.2007Changes to Chapter 5 of the EU GMP Guide Proposed
96713.06.2007FDA's CVM Publishes New Guidances on CMC
96613.06.2007GMP-Compliant Sanitisation of Pharmaceutical Water Systems
96206.06.2007Dr Robert Johnson Appointed Chairman of ECA RMM Working Group
96106.06.2007ICH Q10 Emphasises Quality Management Systems
96006.06.2007Proposed Change for Dissolution Performance Verification Testing
95731.05.2007ICH Publishes Q10 Guideline as Step 2
95630.05.2007Richard Bonner Accepts Nomination as Director Regulatory Affairs for the European Compliance Academy (ECA)
95530.05.2007Final FDA Computerized Systems Guideline available
95430.05.2007OECD Analyses Economic Effects of Counterfeiting and Piracy of Pharmaceuticals
95023.05.2007EMEA Analyses Quality Defects in Centrally Authorised Products
94923.05.2007Supplier Qualification in the Focus of EU GMP Inspectorates
94514.05.2007LIMS/CDS Get More Attention in Inspections
94414.05.2007EMEA Launches EudraGMP Database
92814.05.2007Justification of Limits for Cleaning Validation in the
94109.05.2007European Qualified Person Association
94009.05.2007FDA Withdraws Recognition of Alternative Pharmacopoeias (BP/EP/JP)
93909.05.2007USP Defines New Procedure for Reference Standards
93603.05.2007The Product Quality Review in the Focus of Inspections
93503.05.2007EMEA Reflection Paper on Handling Deviations
93225.04.2007USP Harmonises Requirements on Sterile Water
92719.04.2007EMEA and European Commission Publish Document to Describe the Issue and Update of GMP Certificates
92618.04.2007Annual Review 2006
92517.04.2007Current GMP and Regulatory Developments on
92212.04.2007EMEA Publishes Set of Auditing Documents for Joint Audit Programme
92112.04.2007The UN International Narcotics Control Board Warns of Counterfeit Medicines
91803.04.2007Current FDA Activities
91703.04.2007European Commission Publishes Draft of GMP Directive on Certain Excipients
91428.03.2007Deviations and Failure Investigation - CAPA in the light of FDA Inspections
91328.03.2007UK MHRA Publishes Guidance for Qualified Persons
91021.03.2007FDA Director Steven Galson presents CDER update
90921.03.2007Inspection Deficiencies regarding Validation and Qualification Aspects in EMEA Inspections
90821.03.2007Multi User Version of the GMP Guideline Manager Software for Company Members
90514.03.2007New Version 9.0 of GMP Navigator Software Released under New Name
90314.03.2007Process Validation Again Among the Top Five
90414.03.2007ISPE Publishes New Guideline on Water and Steam Systems
90008.03.2007Pharmaceutical Engineering in the Focus of EMEA Inspections
89908.03.2007Biofilms as the Cause of OOS/OOT Results
89601.03.2007The Product Quality Review gets down to business
89501.03.2007New HMPC Guideline Published
89221.02.2007EMEA Publishes 2007 Work Plan for Ad Hoc GMP Inspection Services Group
89121.02.2007EMEA Publishes Content of the
GMP Inspections Database for the First Time
88814.02.2007FDA Requests More Budget for Public Health Goals
88714.02.2007USP Statement on Dissolution Testing
88407.02.2007Global Efforts in Cold Chain Management and Good Transportation Practice Increase
88307.02.2007New Draft of Chapter 1 "Quality Management" of the EU GMP Guidelines Published
87931.01.2007FDA Requirements on Reporting and Interpreting OOS Results
87831.01.2007FDA 483s Available on the World Wide Web
87424.01.2007List of New, Withdrawn and Revised FDA Guidances Published
87324.01.2007EDQM Publishes TOP TEN Deficiencies Found in Applications for CEPs
87016.01.2007Validation Aspects in US FDA Warning Letters
86916.01.2007EMEA Publishes Concept Paper on Annex 11 - Computerised Systems
86510.01.2007New HMPC Guidelines for Herbal Medicinal Products
86410.01.2007Warning Letters Report 2006
86119.12.2006ECA Working Group on Rapid Microbiological Methods (RMM) Offers Membership
86019.12.2006FDA Advisory Committee discusses new Quality Guidances and Initiatives
85713.12.2006European QP Association's first QP Forum a Complete Success
85613.12.2006Postponed Implementation of USP Microbiology Chapters
85511.12.2006FDA Criticises Maintenance and Cleaning of Equipment
85207.12.2006Active Substance Master File Guideline in Revision
85107.12.2006Publicly accessible Webinar on FDA Study Results
84730.11.2006Comprehensive FDA Study on Inspections and GMP Deviations Published
84630.11.2006EMEA Publishes New Q&A Document on Its Website
84321.11.2006APIC Revises Third-Party Auditing Programme for APIs
84221.11.2006Delegation of GMP-Inspections within the EU
83816.11.2006ICH collaborates with Standards Development Organisations to enforce globalisation of its standards
83716.11.2006Readability of Label and Package Leaflet - Revised Draft of the European Commission
83309.11.2006FDA Defines the "Term Quality Unit"
83208.11.2006Significance of USP General Chapters above <999> for FDA
82831.10.2006Analysis of GMP Inspections by MHRA
82931.10.2006ICH Q9 - Training Material Published
82424.10.2006Draft General Chapter USP <1226> Verification of Compendial Methods Completely Revised
82324.10.2006Eudralex Volume 10 Summarises Requirements on Clinical Trials
82223.10.2006New USP Draft for General Chapter <621> Chromatography with Impact on HPLC System Suitability Tests
81817.10.2006HPLC in FDA Warning Letter
81717.10.2006New ICH Guideline Q4B
81617.10.2006New FDA Activities for Minimising the TSE Risk
81212.10.2006New OOS Guidance by FDA!
81011.10.2006Validation - a New Philosophy Ahead
80805.10.2006FDA Publishes Final Guidance: Quality System Approach to Pharmaceutical cGMP Regulations
80604.10.2006New European QP Association Counts more than 350 Members already
80402.10.2006EMEA Aims at Harmonising the Requirements on Biotechnological Medicinal Products in Clinical Trials
80502.10.2006EMEA Develops GMP Database
80126.09.2006FDA Publishes Guidance Agenda for the Coming Fiscal Year 2007
80026.09.2006Initiative by Members of EU Parliament Calls for GMP Inspections of API Manufacturing Sites within and outside the EU
79720.09.2006New EMEA Guideline on Declaration of Herbal Medicinal Products
79620.09.2006How to Comment FDA Proposed Regulations
79520.09.2006EMEA plans Guideline on Quality of Combination Herbal Medicinal Products
78907.09.2006Product Quality Review - Consequences from the EC GMP Guideline and Authority Expectations
78807.09.2006EMEA supports PAT for Variations
78707.09.2006New USP Chapter for the Pharmaceutical Microbiology
78330.08.2006GMP Webinars Now Available as Recorded Webinars
78230.08.2006EMEA Revises Compilation of Community Procedures
78128.08.2006EMEA Publishes Comments on Draft Guidelines for Herbal Medicinal Products
77721.08.2006Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA)
77621.08.2006New EMEA Guidelines for Herbal Medicinal Products
77521.08.2006EMEA Plans Revision of NIR Guideline
77421.08.2006Annual Review 2006
77110.08.2006European Compliance Academy (ECA) Advisory Board Establishes European Qualified Person Association
77009.08.2006EMEA Reflection Paper on PAT
76428.07.2006European Compliance Academy initiates Working Group for Rapid Microbiological Methods
76328.07.2006PIC/S revises Guide to GMP for Medicinal Products
76118.07.2006ICH Steering Committee Withdraws ICH Q1 F Guideline
76014.07.2006Qualified Person Must Confirm API-Related Notification of Changes
75704.07.2006Is There a List of Equipment for Pharmaceutical Manufacture
Approved by FDA?
75630.06.2006Revision of FDA/EU GMP ISO Matrix - ECA Good Practice Guide
75329.06.2006EMEA's View on the Implementation of RMMs for WFI and Purified Water
75229.06.2006GMP Questions and Answers from the Canadian Authority
74819.06.2006Results of the ECA Survey on Rapid Microbiological Methods - RMMs
74719.06.2006FDA Conducts Workshop for Small Pharmaceutical Businesses
74619.06.2006FDA Announces Withdrawal of 5 and Revision of 2 Guidances
74130.05.2006New FDA Science Forum Documents on Dissolution Testing
74030.05.2006Validation Requirements on the Packaging of Medical Devices
73930.05.2006DoE from the Authorities' Point of View
73524.05.2006Online Seminars Generate Big Interest: Successful Start of the GMP-Webinars
73424.05.2006New EMEA Document on Release Decisions of a Qualified Person
72917.05.2006ASTM Draft Guide: Science- and Risk-Based Approach to Qualification
72815.05.2006FDA's New Validation Approach - The Life Cycle Approach
72712.05.2006EU Requirements on Braille for Printed Packaging Materials
72310.05.2006The current thinking about Rapid Microbiological Methods and PAT
72209.05.2006Risk Management in a New EMEA Paper
72105.05.2006WHO Guidelines on GMP-Compliant Sampling
72003.05.2006The 8th European API Conference in Berlin - A Review
71603.05.2006Withdrawal: FDA's cGMP Regulation and Investigational New Drugs
71428.04.2006FDA's New Compliance Program Guidance Manual, Chapter 45 - Biological Drug Products
71327.04.2006The End of Process Validation?
70919.04.2006Validation of Computerised Systems: Answers to Frequently Asked Questions to GMP Inspectors
70819.04.2006FDA Details Its Visions of the "cGMP for the 21st Century Initiative"
70719.04.2006EMEA Plans Changes in the Field of GMP-Compliant Manufacturing of Investigational Medicinal Products
70411.04.2006Containment Systems under Discussion
70311.04.2006GMP Inspections of Computerised Systems - Which Are the Most Frequent Deficiencies?
70205.04.2006Warning Letters Report 2005
69723.03.2006ECA Internet Survey on Rapid Microbiology
69623.03.2006EMEA plans the revision of various GMP requirements
69523.03.2006New Technical Guide of the European Pharmacopoeia for the Elaboration of Monographs published
69216.03.2006New Version 8.0 of the CD-ROM GMP Navigator Released
69116.03.2006New FDA Compliance Programme�
Guidance for Inspection of API manufacturers
69016.03.2006Media Fills in the Centre of US FDA Warning Letters
68709.03.2006Finally Official: New USP Monograph on Pure Steam
68808.03.2006New EMEA Guideline on Blood and Blood Products
68908.03.2006EMEA Plans Revision of Several Guidelines as well as�
New Guideline on Herbal Medicinal Products
68001.03.2006New Annex 19 "Reference and Retention Samples" Effective June 2006
67928.02.2006New FDA Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
67622.02.2006Current Packaging Materials Requirements
67522.02.2006The new PIC/S AIDE-MEMOIRE "INSPECTION OF BIOTECHNOLOGY MANUFACTURERS"
67014.02.2006New Information on ICH Q10 "Quality Systems"
67114.02.2006Problems with the Integration of ICH Q9 into the European Regulatory System
67209.02.2006New FDA Requirements on the Manufacture of Investigational Drugs for Phase 1
66624.01.2006Mike Edgington Named Director for Regulatory Affairs at ECA
66523.01.2006Lubricants in the GMP and HACCP Surrounding
66420.01.2006In-Vitro Pyrogen Testing - Soon Part of the European Pharmacopoeia?
65702.01.2006New Inspection Guideline for GMP Labs
65802.01.2006New Contents of Annex 1 on Clean-Room Classification
65423.12.2005Inside News: GMP Webinars - The New Online Seminars
65320.12.2005New EMEA Document Questions the 3 Validation Batches for the First Time
65216.12.2005Third-Party GMP Audits of API Manufacturers - EMEA Gives Green Light
64808.12.2005Analysis of GMP Inspections by MHRA
64708.12.2005ICH Q9 on Quality Risk Management Now Available
64101.12.2005EU GMP Guide: New Draft for Annex 1 "Sterile Manufacturing" Published
64401.12.2005ICH Q8 Guideline Now Available in PDF Format
64201.12.2005FDA and EU Extend Confidentiality Arrangements
64325.11.2005Product Recalls Due to OOS Results
63621.11.2005ICH Q8 and Q9 Now Finalised - ICH Q10 on Quality Systems to Come
63521.11.2005Changes to the EU GMP Guide Passed
62925.10.2005EC Commission Publishes the Restructured EU-GMP Guide!
63125.10.2005Statistics on FDA Inspections
63024.10.2005Impurities in Generics - New FDA Draft Guidance for Industry
62517.10.2005ECA Good Practice Guide "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap -"
62312.10.2005FDA Applies for PIC/S Membership
62111.10.2005SOP by EMEA on Inspections
62211.10.2005Laboratory Activities in the Focus of FDA Inspectors
61606.10.2005New ECA Mission Published
61506.10.2005Daniel Scheidegger Appointed New ECA Chairman
61404.10.2005New FDA Developments
61329.09.2005Increase in FDA Warning Letters to European Pharmaceutical Companies
60820.09.2005Revision of the EMEA Inspection Guideline
61020.09.2005"CDER 2004 Report to the Nation" Published by FDA
60414.09.2005Revision of USP Chapter <1116> on Environmental Monitoring
60513.09.2005New USP Drafts on Pharmaceutical Water and Steam
59801.09.2005EDQM's Inspection Programme
59701.09.2005New USP Requirements with an Influence on the Handling of OOS Results
59601.09.2005New EMEA Guideline on Plastic Packaging Materials
59122.08.2005FDA Published ICH Q9 "Quality Risk Management"
59022.08.2005ECA's Annual Advisory Board Meeting in Heidelberg
58922.08.2005Two Recent Warning Letters for Manufacturers of Sterile Products
58815.08.2005FDA Published New Q-and-A on cGMP
58025.07.2005Results of Inspections of Manufacturers of Sterile Medicinal Products
57925.07.2005Which Firms Will the FDA Inspect More Frequently in the Future?
57822.07.2005Current FDA Opinions on Regulatory Affairs, Inspections and GMP
57405.07.2005Young scientists can participate in ECA Biotech Conference free of charge! - Johnson & Johnson donates 5 participations
57304.07.2005Comparability of Biotechnological Products - New Guidance Documents from FDA and EMEA
57204.07.2005Restructuring the EG GMP Guide
56530.05.2005ICH Q9 to Become an Annex to the EU GMP Guide after Being Passed
56330.05.2005GMP Trends: FDA Offices Outside USA? Quo Vadis ICH Q10?
56225.05.2005Biological Product Inspection Issues and Regulatory Update
55924.05.2005New GAMP Good Practice Guide "Validation of Laboratory Computerized Systems" Published
55820.05.2005Barr Judgement on the Internet
55720.05.2005Third-Party GMP Audit at Genzyme Pharmaceuticals
55311.05.2005New Version 7.0 of the CD-ROM GMP Navigator Has Been Released
55210.05.2005EMEA and FDA Intensify Their Co-operation
55109.05.2005New: The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
55025.04.2005ICH Q8 "Pharmaceutical Development" - Background and Important Aspects of Implementation
54925.04.2005Summary of Changes in the Notice to Applicants
53912.04.2005FDA Publishes a New Draft Guideline on Impurities in Raw Materials
54306.04.2005ICH Q 9 on Quality Risk Management published!
53801.04.2005Validation of Computer-Based HPLC Systems
53701.04.2005Stronger Emphasis of Supplier Audits Concerning Packaging Materials
53011.03.2005New GMP Initiative Published by EU Commission and EMEA
52608.03.2005New Draft for a USP Monograph on the Qualification of Analytical Instruments
52507.03.2005FDA Findings During Inspections on Design and Construction of Equipment
52403.03.2005US FDA GRANTED OBSERVER STATUS TO EUROPEAN PHARMACOPOEIA COMMISSION
51922.02.2005EMEA: Activities of Inspections Sector
52122.02.2005Annual Review 2004
51515.02.2005New APIC Guidance on the Qualification of Existing Equipment Published
51414.02.2005FDA Warning Letter Report 2004 Published
51310.02.2005Recently published APIC Industry Best Practice documents
50902.02.2005Frequently Requested Inspection Documents
50702.02.2005PAT (Process Analytical Technology) in Europe
50801.02.2005EMEA Publishes "cGMP Notes"
49629.11.2004FDA White Paper:�Innovation and Continuous Improvement in Pharmaceutical Manufacturing
48810.11.2004FDA and EMEA Presentation on Hot GMP and Regulatory Topics
48726.10.2004Analysis of the Changes Concerning Process Simulation in FDA's New Aseptic Processing Guide
48625.10.2004Which Areas Are Evaluated During FDA Inspections of Laboratories?
48522.10.2004New: ICH Q7A - Side-by-Side Comparison with APIC's How-to-Do Document
48115.10.2004FDA's Final PAT Guidance - Which Changes Have Been Made?
48015.10.2004New FDA Draft Guidance on cGMP for Combination Products
47914.10.2004FDA-Meeting About Follow-on Protein Products
47305.10.2004Risk-ranking Model for Prioritising GMP Inspections - FDA's Pilot Model
47530.09.2004FDA Publishes 5 New Guidances
47229.09.2004ICH Q9 "GMP Risk Management"
47029.09.2004FDA's Dr. Nasr: "I think we are changing the paradigm of how to assess quality of pharmaceuticals in the U.S. and in the world"
46313.09.2004FDA Statement on Media Failures
46110.09.2004Extension of the Scope of Pharmacopoeia Reference Standards Planned
46209.09.2004EU: Quality of Drug Substance in the Dossier - Revised CPMP Guidelines
45424.08.2004New Annex 2 to Note for Guidance on Process Validation
45523.08.2004Dissolution Testing in Human Drug CGMP Notes
44706.08.2004New Q-and-A Website on cGMP by FDA
44304.08.2004FDA Award to Dr Lothar Hartmann and Dr�Norman�Franklin!
44503.08.2004The New FDA Strategy - The Speech of the New FDA Acting Commissioner
44402.08.2004New CPMP Guideline on Impurities in Pharmacopoeial Substances
43821.07.2004Draft for a New Annex 19 to the EU GMP Guide Published
43616.07.2004Inspection Findings Regarding Change Control in Production and Engineering
43515.07.2004EMEA Road Map: Information on Future GMP and GCP Inspections
43201.07.2004FDA Warning Letter Report
43130.06.2004New CPMP Guideline on Plastic Primary Packaging Materials
42718.06.2004FDA Inspection Findings Regarding Manufacturing Equipment
42427.05.2004New FDA Draft Guidances on "Chemistry, Manufacturing, and Control Information (CMC)"
42226.05.2004Latest News on MRA Agreements
42024.05.2004Epilogue to the CONCEPT HEIDELBERG Seminar: Cleanroom Technology in the Focus of the New Guidances "EU GMP Guide Annex 1" and "Aseptic Guide" by the FDA (Held in Mannheim on 4 November 2003)
41907.05.2004Good Distribution Practice and Cold Chain Management �
41806.05.2004Computer Validation: Frequently Asked Questions on GMP/FDA Compliance
41705.05.2004EU Publishes the New EU Directive 2004/27 - Consequences for the GMP-regulated Environment
41322.04.2004Public Meeting on Electronic Records; Electronic Signatures (Part 11), 11 June 2004, Washington D.C.
41122.04.2004New FDA Initiative on Process Validation
40819.04.2004Top Ten of 483 Findings by the FDA in Fiscal Year 2003
40719.04.2004FDA Presentation on Risk Management in Drug Quality
40916.04.2004FDA Has Published Additional HUMAN DRUG CGMP NOTES
40306.04.2004Deviations Regarding Documentation in FDA Warning Letters
40205.04.2004GHTF Guideline on Process Validation
40131.03.2004Revision of Directive 2001/83/EC - Consequences for the API Industry
39712.03.2004New Guideline by the Global Harmonization Task Force (GHTF) on Risk Analysis
39611.03.2004What Does an Inspector Expect of GMP Training and of a GMP Training System?
39123.02.2004GMP/FDA Requirements on HPLC Systems in the Lab
39023.02.2004New FDA Requirements on Filter Validation
38612.02.2004New Requirements on the Validation of Sterility Tests
38511.02.2004New Variations Regulations 1084/2003 and 1085/2003
37210.02.2004The New GAMP Good Practice Guide "Validation of Process Control Systems" (VPCS)
38409.02.2004Annual Review 2003
38305.02.2004New Guidelines and Regulations for the Blood-Processing Industry�
38204.02.2004Evaluation of Warning Letters Concerning Water Systems, Pipes, Dead Legs, and Valves
38103.02.2004New: Addition to the EU GMP Guide
37112.12.2003FDA Develops Quality Systems Guidance(Labcompliance News from Dr Ludwig Huber)
37011.12.2003Adjustment versus Modification - Interpretation of the Ph.Eur. Requirements
36910.12.2003ICH Q8 and ICH Q9 Coming Soon!
42801.12.20036th APIC 2003
36514.11.2003EMEA Plans Revision of the Note for Guidance on Plastic Primary Packaging Materials
36413.11.2003Current Inspection Findings of the British Supervisory Authority MHRA (Formerly MCA)
35520.10.2003FDA Requirements on the Qualification of Component Suppliers
35313.10.2003New PIC/S Guidance on Computer Validation
35122.09.2003Analysis of Our Internet Survey of 28 August 2003
34818.09.2003First Consequences for Process Validation and Equipment Qualification According to the New FDA Draft Guidance on Aseptic Processing
34708.09.2003FDA Draft Guidance for Industry:�Sterile Drug Products Produced by Aseptic Processing
34608.09.2003Final Version: Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application
34508.09.2003NEW:�PAT (Process Analytical Technology) Draft Guidance from FDA!
33928.08.2003Is it possible to fulfil the new requirements of the revised Annex 1 to the EC Guide on the Manufacture of Sterile Medicinal Products?
34027.08.2003FDA's Expectations on the Training Documentation of Laboratory Staff
34126.08.2003Insight into the New ISPE Guide: "Assessing the Particulate Containment Performance of Pharmaceutical Equipment"
33506.08.2003Will the GMP Regulations Be Harmonised Worldwide?
33022.07.2003Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt
32921.07.2003FDA's System-based Approach to Inspections as Reflected in the Warning Letters
32818.07.2003Commission Directive 2003/63/EC: The New Annex 1 to Directive 2001/83/ EC
32118.06.2003FDA Presents Its Analysis of Observations Noted on 483 Forms
31817.06.2003Batch Release and Certification in the European Context - The MRA between Europe and Switzerland
31616.06.2003CPMP Guideline on NIR Adopted
31520.05.2003New Release: GMP Navigator on CD-ROM 5.0
31102.05.2003VDI Guideline 2083 Sheet 8 "Cleanroom Suitability of Operating Materials"
31030.04.2003Changes in the Application Form for a Marketing Authorisation
30929.04.2003FDA's Risk-based Approach - Tools for Risk Analysis
30104.04.2003Risk Classification of GMP Deviations
30003.04.2003Annual Review 2002
29902.04.2003Warning Letters 2002: The Top 10 Complaints Regarding 21 CFR � 211
29426.02.2003FDA Withdraws All Part 11 Guides and Publishes a New Draft
29325.02.2003MRA between EU and Canada Came into Force on 1 February 2003!
29224.02.2003Revision of the PIC/S Document PH 4/93 on the Preparation of a Site Master File
28917.02.2003ISPE's White Paper on "Risk-Based Approach to 21 CFR Part 11"
28815.02.2003Revision of the EMEA Guideline on Stability Testing
of Existing Active Substances and Related Finished Products
28714.02.2003FDA Withdraws Part 11 Guide!
28203.02.2003Social Events
27813.01.2003PIC/S Recommendation on Sterility Testing Revised
27710.01.2003HPLC in FDA Warning Letters
27317.12.2002EU-GMP Guide Annex 1 (Sterile Medicinal Products) to Be Revised
26911.12.20025th European API Conference - Review
26804.12.2002Poll on 21 CFR Part 11
26703.12.2002New WHO Guideline on GMP-compliant Storage - "Good Storage Practices"
26602.12.2002Wallhäußer Award for Drug Quality and Safety Given to Dr L. Huber
26214.11.2002Systems Inspections 2002 - FDA's New Approach to Inspections
26113.11.2002FDA's New Draft Guidance on Electronic Copies of Electronic Records
25806.11.2002Revision of the Variations Regulation - New Proposal released on 25 October 2002 - New Categories of EU-Variations
25630.10.2002Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt
25129.10.2002Warning Letter Report - Data Base Publication
25528.10.2002First Analysis of the New FDA Draft on Aseptic Processing
25325.10.2002Part-11-Compliance CD Finished
24916.10.2002Advanced GMP Search Function
24815.10.2002The Rapid Alert System for the PIC/S Member Countries
24530.09.2002Long-awaited Draft Guide on Aseptic Processing Published
24327.09.2002FDA Slides on ICH Q7A Available
24226.09.2002Calibration Management Guide Published by GAMP
24125.09.20022 Position Papers on APIs published by APIC
24024.09.200221 CFR 211.198 - Complaint Warning Letters in Detail
23517.09.2002Guidances for Part 11 published by FDA on September 5, 2002
23204.09.2002New Initiative by FDA
22928.08.2002New PIC/S Document PI 009-1 "Inspection of Utilities" came into force as AIDE MEMOIRE on 1 July 2002
22827.08.2002New PIC/S Recommendation PI 014-1: "Isolators used for aseptic processing and sterility testing"
22727.08.2002Europe's Answer to the FDA Investigational Manual
22626.08.2002Sterility Testing: PIC/S Document PE 001-2 with Recommendations for GMP Inspectors
22524.08.2002New Monograph on Near Infrared Spectroscopy in the USP
22423.08.2002Draft EMEA Note for Guidance on DMF Procedures
21805.08.2002FDA Requirements to Shipping and Storage Containers
21703.08.2002EMEA Guideline on Water for Pharmaceutical Use Revised
21602.08.2002List of Part-11 Suppliers in the FDA Dockets
21103.07.2002Revision of the Directive 91/356/EEC
21002.07.2002The PECA Agreements on GMP
20901.07.2002Proposed Changes to the Variations Regulation - New Categories of EU Variations
20518.06.2002Warning Letter Report: Overview of the FDA Warning Letters of the Year 2001
19924.05.2002Quality Management System - The Experience of a Medium-sized Cosmetics Company
20123.05.2002Web-based Training Course "A Tour of FDA"
20022.05.2002Check List for Part-11 Systems
19307.05.2002CTD - Transition Period Runs Out on 1 July 2003
19203.05.2002FDA: Federal Standard 209 Replaced
18811.04.2002New PIC/S Draft Guideline on Computer Validation
18708.04.2002FDA-compliant Seal Materials in the Endurance Test
18605.04.2002GMP in Biotechnology
18504.04.2002New FDA Guidance on 21 Cfr Part 11 - »Time Stamps«
18403.04.2002New ICH Guidelines on Stability Testing
17708.03.2002New Draft of Annex 13 - Manufacture of Investigational Medicinal Products
17602.03.2002Do You Already Know the PIC/S Document PI 006-1?
17428.02.2002Revision of the IPEC 'GMP Guide for Bulk Pharmaceutical Excipients' - An important contribution towards drug safety
17328.02.2002On 1 February 2002 the FDA System-based Inspections Came into Force
17528.02.2002Amendment to a European Directive Concerning Traditional Herbal Medicinal Products
17227.02.2002What now, MRA?
19817.02.2002Annual Review 2001
16528.01.2002Revision of the Note for Guidance on Chemistry of the New Active Substance
16009.01.2002New Draft for a CPMP Guideline on Near Infrared Spectroscopy: NIRS in the Dossier for a Marketing Authorisation
15908.01.2002"Note for Guidance on Quality of Water for Pharmaceutical Use"
15517.12.2001Preview of Standards for Cleanroom Technology
15313.12.2001Validation of Analytical Methods: Intermediate Precision
15212.12.2001Quality System Inspection Technique
15108.12.2001New Version of Compilation of Community Procedures on Inspections and Exchange of Information
14615.11.2001Professional Certification Programme
14412.11.2001GMP Deficiencies in Europe
14309.11.2001Essentials of the 4th CEFIC/APIC European Conference on
13910.10.2001Acceptance of Near Infrared Spectroscopy (NIRS) by the Regulatory Authorities
14009.10.2001FDA Draft Guidance for 21 CFR Part 11
13501.10.2001New Books on Pharmaceutical Quality Assurance
13213.09.2001Help with Electronic Records and Electronic Signatures
13112.09.2001New Draft Recommendation on Isolators Used for Aseptic Processing and Sterility Testing
12821.08.2001Measurement Uncertainty
12720.08.2001Annex 1 ge�ndert
12125.07.2001ICH Guideline Published as Annex to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4
12024.07.2001Current Trends in FDA Warning Letters
11919.07.20014 New Annexes to EC GMP Guideline Finalised
11509.07.2001New Books on Pharmaceutical Automation
11402.07.2001New requirements for pharmaceutical water in Europe
11330.06.2001New FDA inspection system
11226.06.2001Zwei neue B�cher von Dr. Michael Jahnke: Mikrobiologisches und Umgebungsmonitoring bei der Media Fill Validierung
10606.04.2001HACCP - getting closer and closer
10503.04.2001News from the USA: BACPAC I now approved
10402.04.2001FDA-Drug Manufacturing Inspections (Pilot Program)
10002.04.2001CD-ROM GMP Navigator 3.0 just released!
9801.03.2001Third Party Audit as a Part of Shared Audits
9701.03.2001Final Draft of Annex 15 published!
9326.02.2001ECA continues its success in 2000
9106.02.2001New European Pharmacopoeia specifications for the system suitability test and for the delimitation between adjustment and modification of a method
9006.02.2001Annex 15 coming.....Annex 15 coming....
8919.01.2001PIC/S Committee Meeting on 24 October 2000
8418.12.2000FDA Requirements to Electronic Signatures and
Records in the Laboratory
8127.11.2000Validation - updating the standards
7825.10.2000New book on Pharmaceutical Quality Systems
7330.09.20003rd European GMP Conference on Active Pharmaceutical Ingredients - Review -
7227.09.2000New: EMEA concept paper on water
7125.09.2000MRA between EC and USA doomed to failure?
7016.09.2000New: FDA guideline on herbal drug products
6503.08.2000Worldwide harmonized GMP for active pharmaceutical ingredients published as "Consensus Draft Guideline"
5620.03.2000CD-ROM GMP-Navigator 2.0 - Free of charge for all participants in an ECA event
5127.12.19991999 ECA's first year a great success
4912.12.1999Trends in validation - News from PIC/S and FDA -
4812.11.1999Pressemitteilung - APIC - 2nd European GMP Conference on Active Pharmaceutical Ingredients
4105.10.1999European Conference on Computer Validation - Conference Review -
3522.06.1999Conference Review on the European Validation Conference, May 4-5 1999, Berlin, Germany
2230.12.1998Conference Report 2nd European GMP Conference
Berlin, December 2 - 3, 1998
1225.09.1998Press Release "First European GMP Conference on Active Pharmaceutical Ingredients", 9-11 September 1998, Br�ssel
Design Control for Drug �Device Combination Products13-14 June 2013, Copenhagen, Denmark