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Current Good Manufacturing Practice (CGMP) Regulations: Division of Manufacturing and Product Quality (HFD-320)
Code of Federal Regulations
In-Process Changes to the Current Good
Manufacturing Practice (CGMP) Regulations
Notes
Other Resources
- Guidance for Industry: CGMPs (Pharmaceutical CGMPs for the 21st Century)
- Field Compliance Programs (Posted 9/11/2003)
- Certificate of a Pharmaceutical
Product Application Instructions.
This application
is required to submit requests for export certificates.
- Subject
Contacts (updated 5/22/2008)
- Sterile Drug Products Produced by Aseptic Processing — Current Good
Manufacturing Practice [HTML]
or [PDF] or [Word]
(Posted 9/29/2004)
- Part 11, Electronic Records; Electronic
Signatures — Scope and Application [HTML]
[PDF] [Word] (Posted 9/25/2003)
- A Review of Procedures for
the Detection of Residual Penicillins in Drugs
- Schering-Plough
- FDA Consent Decree(Posted
5/23/2002)
- Schering-Plough - FDA Complaint for Injunction [HTML]
or [PDF] (5/28/2002)
- Active Pharmaceutical Ingredients -- Guidance Document: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical
Ingredients [HTML]
or [PDF]
- Compressed Medical Gases
- 21 CFR Part 11; Electronic
Records; Electronic Signatures
- Guidance for Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
(Issued October, 2006, Posted 10/16/2006)
- Preamble to Title 21, Subchapter C, Human and Veterinary
Drug, Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding (Issued 1978, Posted 8/28/2000)
- Preparation of
Investigational New Drug Products (Human and Animal) (Issued 11/1992, Posted
3/2/1998)
- Compliance
Program Guidance Manual for FDA Staff, 7356-002: Drug Manufacturing Inspections (1/14/2002)
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Date created: October 13, 2006; Updated February 18, 2009 |
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