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Labcompliance News, October 2001

Oct 3, 2001

Twenty New FDA Warning Letters

In 2001 the FDA has issued several warning letters related to validation, quality assurance and other compliance issues. Cited deviations include: electronic records, data base entries and audit trail, data security, data integrity, computer and software validation, change control, data back-up and archiving, CGMP training, handling non-conformities and out-of-specification (OOS) situation, cleaning validation, method validation, stability testing, failure investigation, complaint procedure, supplier qualification, verification of calculations by a second person, identity and purity tests, management reviews, quality audits, maintenance of equipment, missing meeting records, quality audits, supplier qualification, preventive and corrective actions, QA review, employee competency audits, representative sampling and testing, validation of supplier analysis, microbial contamination, supply chain audit, responsibilities of QC unit. User club members can pre-study keywords and extracts and download all 20 new warning letters. To preview extracts and ordering users club membership, click here

Oct 1, 2001

New Part 11 FDA Industry Draft Guidance on Validation

The United States FDA has released a 24 page draft guidance on validation. The purpose of this draft guidance is to describe the Food and Drug Administration's (FDA’s) current thinking regarding considerations in meeting the validation requirements of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures. It provides guidance to industry, and is intended to assist persons who are subject to the rule to comply with the regulation. It may also assist FDA staff who apply part 11 to persons who are subject to the regulation. 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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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, 2001

New Article on Traceability of Analytical Measurements

There are many supporting elements required to produce analytical data of known quality. Traceability is one quality element. Traceability does not stand-alone, it is one important and critical part of your overall data quality infrastructure. Understanding this quality element and how to use it should enhance your analytical testing program. This article from Carl Craig, Ph.D., General Manager, Pharmaceutical Resource Associate explains the concept of traceability and gives practical examples on how in implement traceability in chemical measurement.