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Labcompliance News, June 2003

June 01, 2003

Five Additional Warning Letters in the User Club

Five FDA Warning Letters have been added to the Labcompliance Users Club section (W-108 to W 112). All are related to GLP, GCP or cGMP in laboratories or manufacturing. Cited deviations include: no corrective and preventive action plan, insufficient detection of impurities, no procedures for in-process testing, inadequate analytical methods validation, insufficient production records, no production record reviews, missing raw data, lack of scientifically sound test procedures, failure to identify unknown peaks, lack of adequate training for laboratory analysts and manufacturing employees, continue testing after OOS results, no collection of content uniformity samples, QA unit not following procedures, no restricted access to unauthorized personnel, equipment not validated (HVAC, Sterilizer, Water Purification System). Warning letters can be downloaded from the Usersclub site. To see extracts and for ordering the Usersclub, click here

June 01, 2003


FDA Published Draft Guidance on Multiplex Tests

The document is intended to provide guidance on preparing and reviewing pre-market approval (PMA) submissions for multiplex tests, or tests that assay multiple analyses simultaneously. Array based tests, such as oligonucleotide, cDNA, protein and tissue arrays, are a subset of multiplex tests. The guidance primarily considers nucleic acid based analyses, but many of the principles apply to protein and tissue arrays as well.

June 01, 2003

Test Procedure: Authorized System Access Added to the Users Club

Limited access to systems and data is a key requirement of all GxP regulations and quality standards. The function is built into most operating systems or application software. However, because of the importance of this functions, it needs to be tested. Missing test documentation can result in 483 observations or warning letters, for an example click here Authorized LAN access through corporate WAN users was not validated (click here) To see an example, click here. Labcomplaince has developed test procedure that includes specifications, step by step test instructions and inspection ready documentation. The procedure can be downloaded from the Usersclub site (C-031). For preview and for ordering the Usersclub, click here

June 01, 2003

Validation and Control of Quantitative Bioanalytical LC/MS Methods

The article describes Validation and control procedures for quantitative bioanalytical liquid chromatography with mass spectral detection (LC/MS) in support of drug development research.