PDA Technical Document Periodic Review

PDA technical documents undergo periodic review to ensure relevance and accuracy of the material. To accomplish this PDA relies on member input from all levels of experience and geographies to ensure the documents are accessible and relevant to a wide audience and up to date regarding industry best practices and regulatory expectations.

To perform your review of a TR listed below, please complete the following steps (you do NOT need to apply to complete your review, just complete the steps below):

1. Download the PDA Periodic Review Excel file to provide your input.
2. Follow the instructions on the “Review Instructions” tab of the file.
3. Once you have completed your review, please rename this Excel file replacing "TR XX" with the TR number you reviewed and send the file to [email protected].

Current Technical Documents Open for Review:

• TR 34 Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products
• TR 45 Filtration of Liquids Using Cellulose-Based Depth Filters
• TR 50 Alternative Methods for Mycoplasma Testing
• TR 51 Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use
• TR 53 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
• TR 58 Risk Management for Temperature-Controlled Distribution
• TR 60-2 Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid Dosage Forms
• TR 63 Quality Requirements for the Extemporaneous Preparation of Clinical Trial
• TR 80 Data Integrity Management System for Pharmaceutical Laboratories
• TR 84 Integrating Data Integrity Requirements into Manufacturing & Packing Operations
• PtC Points to Consider for Aging Facilities
• Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration (PUPSIT Pt 1)
• Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing
• Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators
• Points to Consider for Sensitivity to Oxidation by Peroxide
• PtC Points to Consider in Remote and Hybrid GMP/GDP Inspections

• PDA Member