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Inspection Guides
GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS
FDA Biotechnology Inspection Guide, November 1991
FDA Guide to Inspections of Computerised Systems in Drug Processing,
February 1983
FDA Glossary of Computerized System and Software Development
Terminology
FDA Guide to Inspections of Electromagnetic Compatibility Aspects of
Medical Device Quality Systems
FDA Bioresearch Monitoring Inspections of In Vitro Diagnostic
Devices
FDA Guide to Inspections of Medical Device Manufacturers (12/97)
FDA Guide to Inspections of High Purity Water Systems, July 1993
FDA Guide to Inspections of Lyophilisation of Parenterals, July
1993
FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control
Laboratories, July 1993
FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories,
July 1993
FDA Guide to Inspections of Validation of Cleaning Processes, July
1993
FDA Guide to Inspections of Dosage Form Drug Manufacturers, October
1993
FDA Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval
Issues for Development and Validation, January 1994
FDA Guide to Inspections of Sterile Drug Substance Manufacturers, July
1994
FDA Guide to Inspections of Topical Drug Products, July 1994
FDA Guide to Inspections of Oral Solutions and Suspensions, August 1994
FDA Guide to Inspections of Cosmetic Product Manufacturers, February 1995
FDA Guide to Inspections of Computerised Systems in the Food Processing Industry
FDA Guide to Inspections of Foreign Medical Device Manufacturers (9/95)
FDA Guide to Inspections of Foreign Pharmaceutical Manufacturers, (5/96)
FDA Investigations Operations Manual
FDA Guide to International Inspections and Travel
FDA Inspections Technical Guide (11/87)
FDA Guide to Inspections of Quality Systems (08/99)
FDA Compliance Program Guidance Manual
FDA Compliance Program Guidance Manual 7348.808 Good Laboratory Practice
(02/2001)
FDA Chapter 46: Compliance Program 7346.832: Pre-Approval
Inspections/Investigations
FDA 7346-843 Post-Approval Audit Inspections
FDA Program 7356.002A Sterile Drug Process Inspections
FDA Program 7356.002B Repackers and Relabelers
FDA Program 7356.002C, Radioactive Drugs
FDA Program 7356.002E Compressed Medical Gases
FDA Program 7356.002F Active Pharmaceutical Ingredients (APIs)
FDA Inspections of Licensed Biological Thearpeutic Drug products
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