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Labcompliance News, November 2001

Nov 9, 2001

New FDA Industry Draft Guidance on Bioanalytical Method Validation

This guidance provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies requiring pharmacokinetic (PK) evaluation. This guidance also applies to bioanalytical methods used for non-human pharmacology/toxicology studies and preclinical studies. The information in the guidance generally applies to bioanalytical procedures such as gas chromatography (GC), high-pressure liquid chromatography (LC), combined GC and LC mass spectrometric (MS) procedures such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS performed for the quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urine. 

Nov 9, 2001

The Future State of Computer Validation, Part two published

In September 2001 Pharmaceutical Technology has published the second part of the article series. It has been written by nine world experts and is intended to make computer validation more cost effective. In this part Anthony Trill, a keynote speaker at recent international conferences and senior inspector for the UK Medicines Control Agency, has given his views concerning the validation of computerized systems in the regulated pharmaceutical sector. 

Nov 9, 2001

New Part 11 FDA Industry Draft Guidance with Glossary of Terms

The purpose of this draft guidance is to define terms that will be used in the Food and Drug Administration's (FDA’s) guidances that describe FDA's current thinking on principles and procedures for creating, modifying, maintaining, archiving, retrieving, and transmitting electronic records and electronic signatures under the requirements of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures. Terms include Off-the-Shelf Software (OTS), regression analysis and regression testing. 

Nov 9, 2001

Article Series on 21 CFR Part 11 Available in Japanese

The well known article series on the US FDA's 21 CFR Part 11 written by L. Huber and W. Winter has been translated and customized for Japan by N. Kondo. Topics include an overview, security of systems and applications, data integrity and audit trail, instrument control and data acquisition, data migration for long term archiving and part 11 compliant retrieval.