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Labcompliance News, October 2000

Oct 1, 2000

FDA releases New Industry Draft Guidance on Method Validation

This new guidance provides recommendations to applicants on submitting analytical procedures, validation data, and samples to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. This guidance is intended to assist applicants in assembling information, submitting samples, and presenting data to support analytical methodologies. The recommendations apply to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), product license applications (PLAs), and supplements to these applications. This detailed 37 page guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Oct 1, 2000

New Publications on FDA 21 CFR Part 11 for Laboratories

Bob McDowall, industry consultant in the UK and worldwide specialist on chromatographic data systems, has published a series of articles on '21 CFR Part 11 in laboratories'. These include topics like security aspects, definition of raw data and meta data and applications and limitations of biometric devices for electronic and digital signatures and very useful when implementing electronic records and signatures in laboratories. 

October 1, 2000

New FDA Warning on 21 CFR Part 11: Corrective Action Plan

The FDA continues to issue warning letters with part 11 content. This time the deficiency was, amongst many other things, 'not to have a corrective action plan with time frame for corrections'. A PDF file with the full content can be downloaded from the labcompliance usersclub website. More extracts of FDA warning letters and 483 inspectional observations with Part 11 contents are available from the labcompliance website 483 inspectional observations and warning letters.