A Risk-Based Approach to Pharmaceutical
Current Good Manufacturing Practices (cGMP) for the 21^st Century

Final Report

• Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach Final Report - Fall 2004 (posted 9/29/2004)

Second Progress Report and Implementation Plan

• FDA Press Release (issued September 3, 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] 

Regulations and Guidances

• FDA Takes First Step in Recognizing the Role of Emerging Technologies in the Area of Process Validation  (posted March 17, 2004)
• Part 11, Electronic Records, Electronic Signatures — Scope and Application (final guidance) [HTML]   Optional formats: [PDF] [Word] (posted 9/3/2003)
• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (draft guidance) [HTML]   Optional formats: [PDF]  [Word] (posted 9/3/2003)
• Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice [HTML] or [PDF]
• Comparability Protocols — Protein Drug Products and Biological Products, Chemistry, Manufacturing, and Controls Information (draft guidance) [PDF]  [Word] (posted 9/3/2003)
• PAT — A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (draft guidance) [HTML]   Optional formats: [PDF]  [Word] (posted 9/3/2003)
  
• FR Notice of Availability--Draft Guidance for Industry on Part 11, Electronic Records, Electronic Signatures--Scope and Application  
• Draft Guidance for Industry on Part 11, Electronic Records, Electronic Signatures--Scope and Application  
• FR Notice of Availability--Draft Guidance for Industry on Comparability Protocols Small Molecules  
• Draft Guidance for Industry on Comparability Protocols Small Molecules  

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
• 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, 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

cGMP Archives

• Progress Report, February 20, 2003
  • FDA Press Release
  • Summary Progress Report
  • Questions and Answers
• FDA, GMP Initiative Announcement, August 21, 2002 
• FDA Press Release
• Risk-based Approach Concept Paper
• Questions and Answers

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Date created: February 27, 2003; Last Updated: September 29, 2004

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