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.Related posts:
- Good Pharmaceutical Manufacturing Practice Rationale and Compliance
- Australian code of good manufacturing practice for medicinal products
- New Drug Approval Process (Drugs and The Pharmaceutical Sciences; Vol 190)
- Pharmaceutical Manufacturing Handbook: Regulations and Quality
- New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics (Drugs and the Pharmaceutical Sciences)
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Thanks for visiting and for the email. Sure do.