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.