BSR/PDA Standard 01-201x on Purchasing Controls Available for Public Comment 24 September, 2019

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of BSR/PDA Standard 01-201x, Enhancing Purchasing Controls to Support the Biopharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industry for public comment. To receive a copy of this draft standard, email PDA at [email protected]. The public comments period concludes Nov. 4. There is no charge for the draft standard.

Martin Van Trieste, Civica President & CEO, a former Amgen executive and PDA Immediate-Past-Chair, and Susan Schniepp, industry consultant and former PDA Director, co-chair the purchasing control committee.

“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,” Van Trieste 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 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: 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 [email protected].