Manufacturing

Drugs must be manufactured in accordance with standards called good manufacturing practices, and the FDA inspects manufacturing facilities before a drug can be approved. If a facility isn't ready for inspection, approval can be delayed. Any manufacturing deficiencies found would need to be corrected before approval.

 

Current Good Manufacturing Practice (CGMP) Regulations

Code of Federal Regulations

• CGMP Regulations 21 CFR Parts 210 and 211 (including recent changes to the CGMP regulations at Federal Register Notice, Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule (effective 12/8/2008)
• 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)

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

• Federal Register Notice Final Rule, Partial, Extension of Compliance Date, (7/29/1997); or PDF Version 
• Federal Register Notice Proposed Rule, Revision of Certain Labeling Controls (7/29/1997); or PDF Version 

Other Resources

• Guidance for Industry: CGMPs
• Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination
• Guidance for Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
• Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs
  • Part 11, Electronic Records; Electronic Signatures — Scope and Application [PDF]
• Field Compliance Programs  
  • 7346.832, Pre-Approval Inspections/Investigations  
    • Changes to Compliance Program Guidance Manual (CPGM) 7346.832: Preapproval Inspections/Investigations, Part II Implementation - Inspection Categories that Would Prompt a Preapproval Inspection 
  • 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, Active Pharmaceutical Ingredient (API) Process Inspection
  • 7356.002M,  Inspections of Licensed Biological Therapeutic Drug Products
• 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 Certificates
• Division of Manufacturing and Product Quality Subject Contacts  (updated 12/5/2008)
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice [PDF]
• Part 11, Electronic Records; Electronic Signatures — Scope and Application [PDF]
• A review of procedures for the detection of residual penicillins in drugs [PDF] 
• Schering-Plough - FDA Consent Decree
• Schering-Plough - FDA Complaint for Injunction [HTML] or [PDF] 
• Active Pharmaceutical Ingredients -- Guidance Document: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients [PDF] 
• Compressed Medical Gases  
• 21 CFR Part 11; Electronic Records; Electronic Signatures