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]
  • Memorandum of Understanding (MOU) between the Office of Regulatory Affairs and the Center for Drug Evaluation and Research on the Pharmaceutical Inspectorate [PDF]
    • Pharmaceutical Inspectorate:  Questions and Answers (revised January 2004, posted April 13, 2004)
  • Potential Use of Specialists — An Emerging Team Approach [PDF]
  • Preapproval Inspections (Compliance Program #7346.832) [PDF]

Guidances

• Current Good Manufacturing Practices (CGMPs)/Compliance

cGMP Implementation

• Drug GMP Task Groups

  • Pharmaceutical Working Groups
  • Steering Committee
  • Individual Task Group Membership

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:
  • General cGMP Comments Electronic Docket: Comment Form
  • Comments on the Draft Guidance for Industry on Part 11, Electronic Records, Electronic Signatures--Scope and Application: Comment Form
  • Comments on the Draft Guidance for Industry on Comparability Protocols Small Molecules: Comment Form
• Read Public Comments to the Docket:
  • General cGMP Comments Electronic Docket

 Public Workshop: "A Drug Quality System for the 21^st 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