Typically either the PDA Science Advisory Board (SAB) or the PDA Regulatory Affairs and Quality Committee (RAQC) first determine that there is a lack of clear guidance in an area of science or a regulatory matter involving a previously-published theory or practice pertinent to PDA's mission. The SAB or RAQC then creates a Committee of Experts to study and draft revisions to the publication. The revisions, known as PDA Draft Technical Documents, are posted for a period of time in the Members Only section of www.pda.org, so that PDA members can submit comments to the Committee of Experts.

Following the comment period, the SAB/RAQC Committee of Experts meets to finalize the PDA Draft Technical Document by integrating relevant comments into a PDA Final Technical Report. 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.

Click here to go directly to the current list of PDA Draft Technical Documents (PDA Members only)