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Current Good Manufacturing Practice (CGMP)

• The Current Codified CGMP Regulations 21 CFR, Parts 210 and 211 (Human pharmaceutical products and veterinary products)
  • Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
  • Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
• Biologically derived products (21 CFR 600 and 21 CFR 620)
• Medical devices (21 CFR 820)
• Processed food (21 CFR 100)

CGMPs (Pharmaceutical CGMPs for the 21st Century)

FDA Guidance Document

• Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (Posted 8/4/2004)
• Part 11, Electronic Records; Electronic Signatures — Scope and Application [HTML] [PDF] [Word] (Posted 9/3/2003)
• PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance [HTML] [PDF] [Word] (posted 9/29/2004)
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice [HTML] [PDF] [Word] Posted 9/29/2004

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)