FDA Documents
- Part 210 - cGMPs in Manufacturing, Processing, Packing, or Holding of Drugs; General
- Part 211 - cGMPs for Finished Pharmaceuticals
- 21 CFR Part 600, Subchapter F "Biologics"
- Guideline on Sterile Drug Products Produced by Aseptic Processing
- DRAFT Guideline Sterile Drug Products Produced by Aseptic Processing (2003)
- Guideline on General Principles of Process Validation
- Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (1998)
- 21 CFR Part 11: Electronic Records; Electronic Signatures
CBER Documents
- CBER Guidance Documents
- Cooperative Manufacturing Arrangements for Licensed Biologics
- Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals
- Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
- Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (2001)
- Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation (1999)
- FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacturing of Biological Products (1995)
- Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy (1998)
CDER Documents
- CDER Regulatory Guidance Documents
- Guideline on the Preparation of Investigational New Drug Products (Human and Animal) (1991)
- FDA Compliance Program Guidance
- Drug Manufacturing Inspections Program 7356.002 (2002)
- Inspections of Licensed Biological Therapeutic Drug Products 7356.002M (2003)
- Biotechnology Inspection Guide Reference Materials and Training Aids (1991)
- Compliance Program Guidance Manual for Active Pharmaceutical Ingredients (APIs) 7356.002F
- Guide to Inspections of Bulk Pharmaceutical Chemicals (1994)
- Guide to Inspections of Validation of Cleaning Processes (7/93)
- Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93)
- Inspector's Technical Guide: Heat Exchangers to Avoid Contamination (7/79)