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A Risk-Based Approach to Pharmaceutical
Current
Good Manufacturing Practices (cGMP) for the 21st
Century
Previous Reports, Guidances
and Additional Information
Second Progress Report and Implementation Plan, September 2003
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and Technical Issues Related to Pharmaceutical CGMP (draft guidance) [HTML]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)
- Sterile Drug Products Produced by Aseptic Processing — Current Good
Manufacturing Practice [HTML]
[PDF] [Word]
Posted 9/29/2004
- 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Chemistry, Manufacturing, and Controls Information (draft guidance) [PDF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 Development,
Manufacturing, and Quality Assurance [HTML]
[PDF] [Word]
(posted 9/29/2004)
- FR Notice of Availability--Draft Guidance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- Draft Guidance for Industry on Part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- FR Notice of Availability--Draft Guidance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- Draft Guidance for Industry on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
Task Group Progress Reports (February 2003)
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
Other Reports and Announcements
- FDA, GMP Initiative Announcement, August 21, 2002
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to Top
Final cGMP's Report
Date created: February 27, 2003; Last Updated: July 28, 2006
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