Drugs
-
-
Current Good Manufacturing Practices (cGMP) for Drugs: Reports, Guidances and Additional Information
Second Progress Report and Implementation Plan, September 2003
- Pharmaceutical cGMPs for the 21st Century — A Risk-Based Approach: Second Progress Report and Implementation Plan (issued September 3, 2003)
- International Conference on Harmonisation (ICH) Press Release: "Step 4 for the ICH6 Program" (Brussels, Belgium, Europe, July 17-18, 2003)
- Material Transfer Agreement (MTA) (PDF - 270KB)
- Memorandum of Understanding (MOU) between the Office of Regulatory Affairs and the Center for Drug Evaluation and Research on the Pharmaceutical Inspectorate (PDF - 488KB)
- Pharmaceutical Inspectorate: Questions and Answers (revised January 2004, posted April 13, 2004)
- Potential Use of Specialists — An Emerging Team Approach (PDF - 123KB)
- Preapproval Inspections (PDF - 406KB) (Compliance Program #7346.832)
Guidances
cGMP Implementation
Drug GMP Task Groups
Task Group Progress Reports (February 2003)
- Report on Process Analytical Technology
- Report of the 483 Communications Working Group
- Proposed Process for Dispute Resolution
- Report of the Pharmaceutical Inspectorate Working Group
- Progress Report of the Product Specialists on Inspection Teams Working Group
- Report on Effective Business Practices and Policies in Other Organizations
Public Feedback
- Make Public Comments to the Docket:
- Read Public Comments to the Docket:
Public Workshop: "A Drug Quality System for the 21st Century," April 22-24, 2003, Washington, D.C.
- Workshop Information, including Background, Final Agenda and Breakout Session Topics. Cosponsored by the Product Quality Research Institute (PQRI) and the Food and Drug Administration (updated 4/16/2003)
- Workshop Summary
FDA’s Pharmaceutical Quality Initiatives – Implementation of a Modern Risk-Based Approach, February 28 to March 2, 2007, Bethesda, Maryland
- Workshop Information (7/28/2006)
Other Reports and Announcements
- Progress Report, February 20, 2003
- Summary Progress Report
- Questions and Answers
-
-