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First PDA Standard Out for Public Comment

Sep 30, 2019

PDA proudly announces that its first draft standard, “BSR/PDA Standard 01-201x, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries,” is available for public review and comment. The draft is open for review and commenting until Nov. 4, 2019. To receive your copy and to submit your comments, please email us.

Martin VanTrieste, President and CEO, Civica, and PDA Past-Chair, and Susan Schniepp, industry consultant and former PDA Director, co-chair the committee behind this standard.

“Historically, in our industry the people who make the decisions on which suppliers to select in the negotiations of the contract are not in the quality unit or even manufacturing; they are in procurement or sourcing or a purchasing organization,” VanTrieste said. “We feel it is important not only does everyone have to be involved in the quality of the product, that the people who actually make those decisions are held accountable and this new ANSI standard will help do that.”

PDA is also advancing five other standards:

  • BSR PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing
  • BSR PDA Standard 03-201x, Standard Practice for Quality Risk Management of Aseptic Processes
  • BSR PDA Standard 04-201x, Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters
  • BSR PDA Standard 05-201x, Consensus Method Rating for 0.1 Mycoplasma Reduction Filters
  • Quality Culture (pending ANSI approval)

More information about PDA’s role in standards development can be found on the standards Web page.

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