Technical Reports

PDA Technical Reports cover a wide variety of subjects relating to pharmaceutical production, validation and quality assurance. These global consensus documents are prepared by member-driven Task Forces comprised of content experts including industry, regulatory and academic scientists and engineers. This level of expertise ensures a broad perspective reflecting best thinking and practices currently available.

Once the Task Force has produced a Preliminary Draft, it is vetted through a PDA technical review process. They may also be the subject of discussion at PDA technical forums, where they are discussed by a panel of experts and subjected to questioning by the audience. These forums have been extremely valuable in pointing out needed clarifications prior to publication.

Working Drafts may be shared with other industry stakeholders such as the United States Pharmacopeia (USP), The Pharmaceutical Research and Manufacturers of America (PhRMA), and the US Food and Drug Administration (FDA), and with interested individuals upon request. Comments from these reviews are considered by the Task Force and incorporated into the PDA Draft Technical Report, where appropriate.

When the Task Force is convinced it has produced the Final Draft, it is submitted to the PDA Science Advisory Board (SAB), Biotechnology Advisory Board (BioAB) or the PDA Regulatory Affairs and Quality Committee (RAQC), as appropriate, for review and balloting. Any substantive comments are incorporated into the report prior to publication.

Once approved by an Advisory Board, the Final draft is submitted for review and approval by the PDA's Board of Directors in order to go to publication.

Recent RAQAB related Technical Reports:

PDA Technical Report No. 46 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User
PDA Technical Report No. 46 has sorted through the various distribution regulations in major markets to provide guidance on the proper handling of controlled-temperature medicinal products and devices along the final legs of the distribution chain. 2010. 38 pages.
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PDA Technical Report No. 44, Quality Risk Management for Aseptic Processes - Supplement Volume 62 No. S-1
Provides an overview of a quality risk management program and to present a model to facilitate the risk assessment of aseptic processing of sterile products. 2008. 42 pages
Table of Contents
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