Technical Reports

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world.

These reports are peer-reviewed global consensus documents written by subject matter experts on issues relating to a wide array of challenging technical areas, including use and validation of pharmaceutical filters, sterilization technologies, non-conformities in glass vials and ampoules, pharmaceutical microbiology, glass defects, process validation and good distribution practices, including cold chain, and quality risk management.

Only PDA standard and government members receive the opportunity to download new technical reports free of charge within 30 days of publication as part of their regular membership benefits. To become a PDA standard member, visit www.pda.org/join today.

Access Technical Reports through PDA’s Technical Report Portal

Technical Report Portal

Visit PDA's New Technical Report Portal

Learn how to use the portal: Access, Navigate and Select TRs.

In this portal, PDA Standard and Government Membersare able to view the complete library (or collection) of active PDA Technical Reports.

All print versions of the PDA Technical Reports are available for purchase at the PDA Bookstore.

Here is a short-list of the most recent Technical Reports:

PDA 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

This technical report provides specific case study examples of how to apply quality risk management to the manufacturing of pharmaceutical drug products.
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PDA Technical Report No. 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

This technical report was written to establish industry-wide criteria on what constitutes an acceptable alternative or rapid microbiology test to the compendial or classical method and how to prove it to the satisfaction of quality organizations and regulatory agencies.
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PDA Technical Report No. 64 (TR 64), Active Temperature-Controlled Systems: Qualification Guidance

This guidance discusses the process of qualifying actively controlled spaces that are designed to maintain a stable and uniform temperature around the cargo for the duration of transportation or storage at any temperature range.
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PDA Technical Report No. 43, Revised 2013 (TR 43) Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing

The 2013 revision of Technical Report No. 43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing: Covering Ampules, Bottles, Cartridges, Syringes and Vials provides the building blocks for developing an overall specification for molded bottles, vials and tubular glass containers.
Table of Contents

PDA Technical Report No. 63 (TR 63) Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials

Technical Report No. 63: Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials describes a quality system that will support the preparation of clinical trial materials in a nonmanufacturing environment in a manner that will ensure product quality and patient safety.
Table of Contents

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