Source: http://labcompliance.com/news/2013/11_nov_news.aspx
Timestamp: 2019-10-23 04:59:46
Document Index: 60488196

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Violations related to FDA's Part 11 are still an issue. Recent examples are a series of inspections with warning letters related to security, integrity and availability of electronic records. Here are a few citations: "Your firm’s HPLC systems do not have restrictions in place to prevent any change or deletion of analytical raw data". "During the review of the chromatography data, our investigator noticed that the raw data retained does not include the run sequence or the processing method used to perform the peak integrations" and "Several of the HPLCs had the audit trail functions disabled; therefore, there is no assurance that the data generated using these HPLCs is accurate" .The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-287, 286 and 284. Non members can preview excerpts. A very effective way to learn everything about most up-to-date FDA requirements and to get tools such as a master plan, step-by-step implementation guide, SOPs and checklists is to study the new Part 11 compliance package. The package also includes examples of 20+ full text warning letters with citations related to Part 11.
FDA Releases a Draft Guidance on Elemental Impurities
Shortly after ICH has published the draft guidance on elemental impurities the FDA released the same documents as FDA draft guidance. The guidance lists 4 classes of elements with permitted daily exposure limits and includes risk based control strategies for drugs and APIs to reduce the elements to be below the limits. The guidance does not describe analytical procedures but refers to related regional Pharmacopeias. The guidance can be viewed and downloaded from the FDA website. The elements and limits are similar but not identical to the USP chapter 232. To learn about similarities and differences between USP and ICH attend the recent Labcompliance audio seminar 'Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines'. .
Labcompliance is introducing Version 3.1 of it's popular Part 11 Compliance Package . The content has been updated with 20+ new or updated good practice guides, e.g., master plan, implementation guide, SOPs. checklists, examples and forms. The new package is ideally suited to prepare companies for the ongoing FDA Part 11 inspections with focus on security, integrity and availability of e-records. For example, SOPs are available addressing security and integrity and checklists, the step-by-step implementation plan and the Part 11 compliance master plan have been updated accordingly. For details on content and ordering, click here
FDA Requests a Retrospective Review of all Drugs manufactured at a Facility after Improper Laboratory Testing
During a recent inspection of a drug manufacturer the FDA found significant deficiencies during drug testing. In the follow-up warning letter the FDA requested a retrospective review of all drugs manufactured at that facility. The letter reads: "The investigation should provide detailed descriptions of other incidents where your quality unit failed to ensure proper testing of materials and should include a retrospective review of all test results generated by your laboratory personnel. If other instances of non-existent, inaccurate, or unreliable test results are found, your investigation should assess the impact of these discrepancies on the quality of the drug products manufactured at your facility". The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-284. Non members can preview excerpts. Such extensive follow-up with possible product recalls is part of FDA's new inspection and enforcement practice. To learn more about the new practice attend the new Labcompliance audio seminar 'Are You ready for FDA's 'New' Inspection and Enforcement Practices?'.
New Article on Analysis of Biopharmaceuticals for ICH Q6B Compliance
The article written by David Neville and Andrew Kenyon highlights some of the analytical techniques that are used when setting specifications for biomolecules to meet the guidelines set out in the document ‘Specifications: Test Procedures and Acceptance Criteria For Biotechnological/Biological Products according to ICH Q6B. Analytical techniques as discussed in the article include Electrophoresis, Mass Spectrometry, N-linked Glycosylation, Quantitative PCR (qPCR) and ELISA As of October 2013 the article is available on the in-PharmaTechnologist.com website It also includes a link to the draft proposals. Copyright rests with the publisher.
As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP "Revalidation of Software and Computer Systems". To download your free copy, go to the Macro and Spreadsheet Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on December 15, 2012). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here
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