| Current Good Manufacturing Practice (CGMP) |
| CGMP Regulations: Division of Manufacturing and Product Quality (HFD-320) |
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CGMPs (Pharmaceutical CGMPs for the 21st Century) -- Draft FDA Guidance Document- Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information [HTML] [PDF] [Word] (Posted 9/3/2003)
- Current Good Manufacturing Practice for Combination Products [HTML] [PDF] [Word] (Posted 9/29/2004)
- Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP [HTML] [PDF] [Word] (Posted 9/3/2003)
- Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment [HTML] [PDF] or [Word] (Issued 11/2003, Posted 11/6/2003)
- Revised Attachments [Word] or [PDF] (Issued 11/2003, Posted 11/21/2003)
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations [HTML] [PDF] [Word] (Posted 9/29/2004)
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| Canadian Good Manufacturing Practices |
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| European Union Good Manufacturing Practices regarding medicinal products for human and veterinary use |
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