OCBQ/DMPQ/Manufacturing and Review Branch 1 and Branch 2
The Manufacturing and Review Branch 1 and Branch 2 recommend the following resources for manufacturers.
Frequently Requested FDA Guidances
- Good Review Management Principles and Practices for PDUFA Products
- Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
- Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice
- Process Validation: General Principles and Practices
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
- Guidance for Industry: M4: Organization of the CTD
- Guidance for Industry: M4Q: The CTD - Quality
Frequently Requested Federal Register Notices
- FR Notice, Vol. 43, No. 190, September 29, 1978: Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding (Final Rule)
- FR Notice, Vol. 72, No. 201, October 18, 2007: Revision of the Requirements for Live Vaccine Processing
- FR Notice, Vol. 73, No. 174, September 8, 2009: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
- FR Notice, Vol. 77, No. 86, May 3, 2012: Amendments to Sterility Test (final rule)