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News and Events:

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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