PDA Launches Third Industry Standard: Standard Practice for Quality Risk Management of Aseptic Processes 7 August, 2019

Bethesda, Md. –   PDA today announces the official launch of its third standard project, “Standard Practice for Quality Risk Management of Aseptic Processes” which is being chaired by Hal Baseman, Chief Operating Officer of ValSource, Inc.

Throughout 2019, PDA has made significant progress advancing its first two standards, “Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries” and “Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing.” Both preliminary drafts will be made available to the public for review in the coming months.

The final steps are underway to put together a working group for a fourth standard, “Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters,” and a 60-day open call for volunteers has just begun for a fifth standard, “Consensus Method for Rating 0.1 Mycoplasma Reduction Filters,” following an ANSI review.

In 2017, PDA earned approval from the  Executive Standards Council (ExSC) of the American National Standards Institute (ANSI) as an Accredited Standard Developer (ASD) because its portfolio of technical reports, which has grown to nearly 80 active documents, included a number of topics that were excellent candidates to become American National Standards.

More information about PDA’s role in standards development can be found here https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi.

Find answers to standard development questions https://www.pda.org/scientific-and-regulatory-affairs/pda-standards-frequently-asked-questions or reach out to standards@pda.org.