Current Good Manufacturing Practice (CGMP) Regulations: Division of Manufacturing and Product Quality (HFD-320)

Code of Federal Regulations

• The Current Codified CGMP Regulations 21 CFR, Parts 210 and 211

In-Process Changes to the Current Good Manufacturing Practice (CGMP) Regulations

• Federal Register Notice Proposed Rule, Proposed Changes to the CGMP Regulations about Validation, Out-of-Specification Findings, etc. (5/3/96)
• Federal Register Notice Final Rule, Partial, Extension of Compliance Date, (7/29/97); or Acrobat Version
• Federal Register Notice Proposed Rule, Revision of Certain Labeling Controls (7/29/97); or Acrobat Version

Notes

• Human Drug CGMP Notes (3/1995-7/2000)
• Human Drug CGMP Notes (1/1993-12/1994)  
  • [CNOTES vol. 1 no. 1 Feb 1993] 
  • [CNOTES vol. 1 no. 2 May 1993]  
  • [CNOTES vol.1 no. 3 Sept 1993]  
  • [CNOTES vol.1 no. 4 Dec 1993]  
  • [CNOTES vol. 2 no. 1 Mar 1994]  
  • [CNOTES vol. 2 no. 2 Jun 1994]   
  • [CNOTES vol. 2 no. 3 Sep 1994]   
  • [CNOTES vol. 2 no. 4 Dec 1994]

Other Resources

• Guidance for Industry: CGMPs (Pharmaceutical CGMPs for the 21st Century)
  • 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)
     
• Field Compliance Programs  (Posted 9/11/2003)
  • 7346.832, Pre-Approval Inspections/Investigations   (3/15/2004)
    • Changes to Compliance Program Guidance Manual (CPGM) 7346.832: Preapproval Inspections/Investigations, Part II Implementation - Inspection Categories that Would Prompt a Preapproval Inspection.  (Posted 9/5/2003)
  • 7346.843, Post-Approval Audit Inspections
  • 7356.002, Drug Process Inspections
  • 7356.002A, Sterile products manufacture
  • 7356.002B, Repackers and relabelers
  • 7356.002C, Radioactive drugs
  • 7356.002E, Compressed medical gases
  • 7356.002F, Bulk pharmaceutical chemicals
  • 7356.002M,  Inspections of Licensed Biological Therapeutic Drug Products [HTML] or [PDF] (10/20/2003)
   
• Certificate of a Pharmaceutical Product Application Instructions.   This application is  required to submit requests for export certificates.
  • Format for an Export Certificate Application

  • Guidance Document: FDA Export Certicates [HTML] or [PDF]

• Division of Manufacturing and Product Quality Subject Contacts  
• 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
• Draft Guidance for Industry; Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production, 9/30/98
• 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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FDA/Center for Drug Evaluation and Research
Last Updated:   October 5, 2004
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