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Synopsis
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of...
Review
an impressive achievement....a volume that should guide and influence those who plan to be perfect in acquiring a detailed education and review of the GLP requirements and desire to exercise responsibility in the Quality Control function.
-Current Engineering Practice (for previous edition) --a
"About this title" may belong to another edition of this title.
- PublisherCRC Press
- Publication date2007
- ISBN 10 0849375835
- ISBN 13 9780849375835
- BindingHardcover
- LanguageEnglish
- Edition number4
- Number of pages304
- EditorWeinberg Sandy
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Good Laboratory Practice Regulations (Drugs and the Pharmaceutical Sciences)
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Good Laboratory Practice Regulations
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Good Laboratory Practice Regulations (Hardcover)
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Taylor & Francis Inc, Bosa Roca, 2007
ISBN 10: 0849375835
ISBN 13: 9780849375835
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Hardcover. Condition: new. Hardcover. Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated proceduresgives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documentsand details the FDAs GLP inspection program. Good Laboratory Practice Regulations Shipping may be from multiple locations in the US or from the UK, depending on stock availability. Seller Inventory # 9780849375835
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Good Laboratory Practice Regulations
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Good Laboratory Practice Regulations (Drugs and the Pharmaceutical Sciences)
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