Food and Drug Administration

Process Analytical Subcommittee of the Pharmaceutical Science Advisory Committee

October 23, 2002

Briefing Information

Memorandum to the Committee Members and Discussants, Dr. Ajaz Hussain, PhD, FDA  HTM  PDF  Word

Process Analytical Technology Initiative Rapid Microbiology Methods  HTM  PDF  Word

General Principles of Software Validation; Final Guidance for Industry and FDA Staff  PDF

Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices  PDF

Guidance for Industry Computerized Systems Used in Clinical Trials PDF

Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Glossary of Terms  PDF

Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Validation  PDF

Computerized Devices/Processes Guidance - Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes, Medical Device GMP Guidance for FDA Investigators, May 1992  PDF

Validation Perceptions That May Slow PAT Development and Implementation, Steve Hammond, Pfizer Global Manufacturing  HTM  Ppt

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach  PDF  Word