Technical Report No. 57 (TR 57) Analytical Method Validation and Transfer for Biotechnology Products
Document status: Active
Technical Report No. 58 (TR 58) Risk Management for Temperature-Controlled Distribution
Document status: Active
Technical Report No. 59 (TR 59) Utilization of Statistical Methods for Production Monitoring
Document status: Active
Technical Report No. 60-2 (TR 60-2) Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms
Document status: Active
Technical Report No. 60-3 Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing
Document status: Active
Technical Report No. 60 (TR 60) Process Validation: A Lifecycle Approach
Document status: Active
Technical Report No. 62 (TR 62) Recommended Practices for Manual Aseptic Processes
Document status: Active
Technical Report No. 63 (TR 63) Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials
Document status: Active
Technical Report No. 64 (TR 64) Active Temperature-Controlled Systems: Qualification Guidance
Document status: Active
