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 12 Siliconization of Parenteral Drug Packaging Components
• TR 28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals
• TR 34 Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products
• TR 38 Manufacturing Chromatography Systems Post-approval Changes (ChromPAC): Chemistry, Manufacturing, and Controls Documentation
• TR 48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
• TR 52 Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain
• TR 59 Utilization of Statistical Methods for Production Monitoring
• TR 60-2 Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid Dosage Forms
• TR 61 Steam In Place
• TR 69 Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations
• TR 74 Reprocessing of Biopharmaceuticals
• TR 76 Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging
• TR 80 Data Integrity Management System for Pharmaceutical Laboratories
• TR84 Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

• PDA Member