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Technical Reports

PDA Technical Reports cover a wide variety of subjects relating to pharmaceutical production, validation and quality assurance. These consensus-driven documents are prepared by PDA member Technical Report Team (TRT) comprised of content experts including industry, regulatory and academic scientists and engineers from around the globe. This level of expertise ensures a broad perspective from thought leaders reflecting current best practices.

Once the TRT 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), as well as with interested individuals upon request. Comments from these reviews are considered by the TRT and incorporated into the PDA Draft Technical Report, where appropriate.

When the TRT 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 publication approval by the PDA Board of Directors.

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