Technical Report No. 53 (TR 53) Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
Document status: Active
Technical Report No. 54-2 (TR 54-2) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling
Document status: Active
Technical Report No. 54-3 (TR 54-3) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products
Document status: Active
Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances
Document status: Active
Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems
Document status: Active
Technical Report No. 54-6 (TR 54-6) Formalized Risk Assessment for Excipients
Document status: Active
Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
Document status: Active
Technical Report No. 55 (TR 55) Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries
Document status: Active
Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)
Document status: Active
Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnology Products
Document status: Active
