Technical Report No. 83 (TR 83) Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response

Technical Report No. 80 (TR 80) Data Integrity Management System for Pharmaceutical Laboratories

Technical Report No. 79 (TR 79) Particulate Matter Control in Difficult to Inspect Parenterals

Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms

Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

Technical Report No. 60-2 (TR 60-2) Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms

Technical Report No. 77 (TR 77) The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

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)

Technical Report No. 76 (TR 76) Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging

Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1?m Mycoplasma Reduction Filters