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.

Recently Published TRs:

PDA Technical Report No. 51 Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use
Technical Report No. 51 Provides a comprehensive review of an area not adequately addressed in current guidance documents: recommended specifications for BIs to be used with sporicidal gas and vapor-phase decontamination cycles together with guidance regarding their manufacture, quality control, and use. 2010.
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PDA Technical Report No. 49 Points to Consider for Biotechnology Cleaning Validation
PDA Technical Report No. 49 Points to Consider for Biotechnology Cleaning Validation aligns cleaning validation practices with the life cycle approaches to validation, as enabled by the International Conference on Harmonisation guidelines on pharmaceutical development (Q8), quality risk management (Q9) and quality systems (Q10).
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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. 26, Revised 2008, Sterilizing Filtration of Liquids - Supplement Volume 62 No. S-5
PDA's original Technical Report No. 26, published in 1998 described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. This revision was developed in response to enhancements in filtration technologies and recent additional regulatory requirements within the pharmaceutical industry. It underwent an eleven-week global technical peer review that included feedback from the Americas, Asia-Pacific and Europe. 2008. 62 pages.
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PDA Technical Report No. 45, Filtration of Liquids Using Cellulose-Based Depth Filters - Supplement Volume 62 No. S-2
Provides a current industry perspective and scientific guidance on the validation of column-based separation processes for the purification of biopharmaceutical proteins. 2008. 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
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