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Labcompliance News, July 2004

July 9, 2004

FDA's Expectations for Laboratory Method Validation and Instrument Qualification

It's difficult to find documented specific acceptance criteria from the FDA for the validation of analytical methods and equipment. FDA's Dr. Moheb M. Nasr, Division of Pharmaceutical Analysis at CDER. Dr. Nasr gave an interesting presentations with a lot of such details. The presentation starts with a statistics on Drug GMP 483's and Warning Letters: The majority of the cited deviations are related to Laboratory Systems. Dr. Nasr continues with specific recommendations for validation of HPLC procedures and qualification of systems. He follows the 4Q lifecycle model and gives examples for DQ, IQ, OQ, and PQ. He also gives FDA's expectations on what should be included in System suitability. The presentations ends with examples of FDA 483's and Warning Letters and with FDA's expectations on how to avoid them. Labcompliance Usersclub members can download the presentations. For preview and ordering, click here. The warning letter examples and recommendations on how to avoid them will also be discussed in the upcoming on-line seminar on 'FDA Inspections'.

July 17, 2004

Special Offer for Network Qualification

Labcompliance offers a recorded audio seminar and a network quality package to help validation specialists and QA and IT specialists to qualify network infrastructure and validate network systems. They seminar and the package include audio and video presentations (resp.) and SOPs, checklists and examples for easy implementation. Since July 2004 the recorded audio seminar reference material also includes the proposed IVT Standard: Network Infrastructure Qualification. This proposed standard has been developed and/or by network and compliance specialists from industry and the FDA. Labcompliance visitors get 30% discount when they order both.

July 9, 2004

Recent FDA Warning Letter for Invalidation of Tests Results Without Adequate Scientific Rationale

In a warning letter from April 2004 the FDA cited a firm for invalidation of analytical tests results without documenting assignable causes or adequate scientific rationale. Lots were originally rejected, but later were re-sampled, retested, and released for distribution based on the retest passing results. Retesting was performed with additional new samples from the lot rather than with the original sample, as required by the procedure. Other deviations cited in the warning letter have been: need for revalidation of a chromatographic data system not evaluated after addition of new acquisition servers, inadequate SOPs, no management review of laboratory test data, no or inadequate failure investigations, inadequate complaint handling procedures, custom-made calculations of automated systems not verified with manual calculations. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.

July 8, 2004

Case Study: Upgrading a Pharmaceutical Laboratory to Part 11 Compliance at AstraZeneca.

In a Biopharm Publication Dr. Akos Bartha and Karin Östergren describe efforts by the Liquid Products Supply (LPS) site at AstraZeneca Sweden Operations to bring its quality control (QC) laboratory into compliance with Part 11. The study describes a strategy for both procedural and technical solutions within the broader context of AstraZeneca's corporate project for Part 11 compliance. It shows that a successful strategy for Part 11 compliance includes management commitment and cooperation of business, QA, and IT. The article concludes with a list of documents that should be available for inspections.

July 8, 2004

Who is responsible for the Validation of Computer Systems?

The question about responsibility for computer validation comes up frequently. Suggested functions have been quality assurance, IT, validation groups, regulatory affairs, operations (end-users) and vendors of commercial of the shelf systems. The FDA does not specify who is responsible for computer validation. This decision will depend on the specific situation of each organization. Frequently validation tasks are a joint effort of representatives from different departments and are lead by the system owner. Most important is that responsibilities are clearly defined and documented in procedures.

July 4, 2004

What is the Problem with SOPs?

"No adequate procedures" or "procedures not followed" are amongst the most frequently cited deviations in FDA Warning Letters and 483's. Probably all FDA regulated companies have SOP's but why is it that they are not accepted and used by their employees and by the FDA? There seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors. SOPs are either not available for specific processes or tasks or they are not followed by employees. Click here to learn how to write SOPs that will be accepted by the FDA and by your employees.