PDA Final Technical Reports cover a wide variety of subjects relating to pharmaceutical production, validation and quality assurance. These reports are prepared by Task Groups composed of experts in the areas directly related to the subject of the particular report. The experts are industry scientists and engineers and often include regulators, such as FDA representatives. This level of expertise ensures the completed report will reflect the best thinking and practice currently available.

Once the Task Group has produced a preliminary draft, the draft report is made widely available for comment. The draft is posted for member comment in the PDA Draft Technical Documents page in the Members Only section of PDA's Web site, sent to PDA's principal representatives, provided to various relevant organizations such as the United States Pharmacopeia (USP), The Pharmaceutical Research and Manufacturers of America (PhRMA), and the US Food and Drug Administration (FDA), and shared with interested individuals on request. Comments from these reviews are considered by the Task Group and incorporated into the PDA Draft Technical Report, where appropriate.

When the Task Group is convinced it has produced the best document possible, the draft is submitted to an independent expert editorial review team for comprehensive peer review. Any substantive comments are incorporated into the report prior to publication.

Technical Reports are also 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.

Final review and approval authority rests with PDA's Board of Directors. All PDA Final Technical Reports must pass this hurdle prior to publication.

PDA Final Technical Report (xls)

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