Source: http://www.scribd.com/doc/130409848/WHOAnnex4-Validation
Timestamp: 2014-09-23 07:22:12
Document Index: 359294296

Matched Legal Cases: ['art4', 'art7', 'art3', 'art2', 'art1', 'art1']

WHOAnnex4 Validation
P. 1WHOAnnex4 ValidationWHOAnnex4 ValidationRatings: (0)|Views: 3
|Likes: 0Published by lanikhilMore info:Published by: lanikhil on Mar 14, 2013Copyright:Attribution Non-commercialAvailability:Read on Scribd mobile: iPhone, iPad and Android.download as PDF, TXT or read online from ScribdFlag for inappropriate content|Add to collectionSee moreSee lesshttp://www.scribd.com/doc/130409848/WHOAnnex4-Validation03/14/2013pdftextoriginal 107
Supplementary guidelines on good manufacturingpractices: validation
1. Introduction2. Scope3. Glossary4. Relationship between validation and qualiﬁcation5. Validation5.1. Approaches to validation5.2. Scope of validation6. Qualiﬁcation7. Calibration and veriﬁcation8. Validation master plan9. Qualiﬁcation and validation protocols10. Qualiﬁcation and validation reports11. Qualiﬁcation stages12. Change control13. PersonnelReferencesAppendix 1
Validation of heating, ventilation and air-conditioning systems
Validation of water systems for pharmaceutical use
Qualiﬁcation of systems and equipment
Validation is an essential part of good manufacturing practices (GMP). It is,therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance haveas their goal the production of products that are ﬁt for their intended use.These principles are as follows:
Quality, safety and efﬁcacy must be designed and built into the product.
Each critical step of the manufacturing process must be validated. Other steps in the process must be under control to maximize the probabilitythat the ﬁnished product consistently and predictably meets all qualityand design speciﬁcations.
Validation of processes and systems is fundamental to achieving these goals.It is by design and validation that a manufacturer can establish conﬁdence thatthe manufactured products will consistently meet their product speciﬁcations.
Documentation associated with validation includes: — standard operating procedures (SOPs) — speciﬁcations — validation master plan (VMP) — qualiﬁcation protocols and reports — validation protocols and reports.
generally validation work is subject to rigorous time schedules.
validation often requires the time of specialized personnel and expensive technology.
validation requires the collaboration of experts from various dis-ciplines (e.g. a multidisciplinary team, comprising quality assurance, en-gineering, manufacturing and other disciplines, depending on the productand process to be validated).
These guidelines aim to give guidance to inspectors of pharmaceutical manu-facturing facilities and manufacturers of pharmaceutical products on therequirements for validation. The main part covers the general principles of validation and qualiﬁcation. In addition to the main part, appendices on vali-dation and qualiﬁcation (e.g. cleaning, computer and computerized systems,equipment, utilities and systems, and analytical methods) are included.
2.1 These guidelines focus mainly on the overall concept of validationand are intended as a basic guide for use by GMP inspectors and manufac-
turers. It is not the intention to be prescriptive in speciﬁc validation require-ments. This document serves as general guidance only, and the principlesmay be considered useful in its application in the manufacture and controlof active pharmaceutical ingredients (APIs) and ﬁnished pharmaceutical products. Validation of speciﬁc processes and products, for example in ster-ile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document.2.2 There are many factors affecting the different types of validation and it is, therefore, not intended to deﬁne and address all aspects related to one particular type of validation here.2.3 Manufacturers should plan validation in a manner that will ensureregulatory compliance and ensuring that product quality, safety and consis-tency are not compromised.2.4 The general text in the main part of these guidelines may be appli-cable to validation and qualiﬁcation of premises, equipment, utilities and systems, and processes and procedures. More speciﬁc principles of quali-ﬁcation and validation are addressed in the appendices. Semi-automatic or fully automatic clean-in-place (CIP) systems and other special cases should be treated separately.
The deﬁnitions given below apply to the terms used in these guidelines.They may have different meanings in other contexts.
calibration The set of operations that establish, under speciﬁed conditions, the relation-ship between values indicated by an instrument or system for measuring(for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding knownvalues of a reference standard. Limits for acceptance of the results of mea-suring should be established.
computer validation Documented evidence which provides a high degree of assurance that acomputerized system analyses, controls and records data correctly and thatdata processing complies with predetermined speciﬁcations.
commissioning The setting up, adjustment and testing of equipment or a system to ensurethat it meets all the requirements, as speciﬁed in the user requirement speci-ﬁcation, and capacities as speciﬁed by the designer or developer. Commis-sioning is carried out before qualiﬁcation and validation.
Added to My Library Click again to add to a collection Contract QPs
Added to My Library Click again to add to a collection API Focussed Mhra Inspections at Dosage Form Mfg
Added to My Library Click again to add to a collection Gmp Expectation of Non Traditional API - Mhra
Added to My Library Click again to add to a collection Water Part4
Added to My Library Click again to add to a collection HDS Pipeline En
Added to My Library Click again to add to a collection Who Par Guidance With Appendixes
Added to My Library Click again to add to a collection QA Pharmaceuticals Vol2
Added to My Library Click again to add to a collection Validation Part7
Added to My Library Click again to add to a collection Hvac Part3
Added to My Library Click again to add to a collection Hvac Part2
Added to My Library Click again to add to a collection Hvac Part1b
Added to My Library Click again to add to a collection Hvac Part1a
Added to My Library Click again to add to a collection Single Line Drawing of PCC Panel
Added to My Library Click again to add to a collection Single Line Drawing of APFC Panel
Added to My Library Click again to add to a collection Panel Specifications
Added to My Library Click again to add to a collection MAIN PCC GA
Added to My Library Click again to add to a collection Lt Panels - Boq
Added to My Library Click again to add to a collection CBP GA
Added to My Library Click again to add to a collection 11KV Metal Clad VCB Specifications
Added to My Library Click again to add to a collection water USP
Added to My Library Click again to add to a collection Lab Grade Water
Added to My Library Click again to add to a collection Electronics Grade Water