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News about GMP/cGMP

2017-04-04

PDA Becomes an ANSI Accredited Standard Developer

Anaheim, Ca.  April 3, 2017 – A press release by Walt Morris, Senior Director of Publishing at PDA (Parenteral Drug Association)

The Parenteral Drug Association (PDA) today announced that it has been approved by the Executive Standards Council (ExSC) of the American National Standards Institute (ANSI) as an Accredited Standard Developer (ASD). The announcement was made during the opening session of PDA’s Annual Meeting at the Anaheim Marriott.

 

With a membership comprised of subject-matter-experts on a variety of subjects, PDA already had in place a rigorous peer review process for our technical report program that includes review and approval by various advisory boards and our Board of Directors,” said Richard Johnson, PDA President. “It does not require a great leap for PDA to move into the standards-setting arena.

PDA was approved by ANSI to be an ASD because PDA’s portfolio of technical reports, which has grown to nearly 80 active documents, includes a number of topics that are excellent candidates to become American National Standards. In addition, PDA has a long history of working with other organisations, including the United States Pharmacopeia (USP) and the American Society of Mechanical Engineers (ASME), to ensure PDA’s activities do not duplicate or contradict other recommended practices.

PDA’s science program historically has addressed topics that fill gaps that exist in existing regulations and standards used by manufacturers of sterile drug products,” said Richard Levy, PhD, PDA Sr. VP of Scientific and Regulatory Affairs. “Our series of technical reports on aseptic processing and sterile manufacturing, microbiology, and drug/device packaging and delivery systems, such as prefilled syringes, are examples of documents that would be good candidates to become American National Standards.

Additionally, approval to become an ASD was granted based upon standards development procedures PDA has developed that meet or exceed ANSI’s due process requirements and that PDA will ensure adequate resources are dedicated to standards development. To review PDA’s current standards development policies and procedures, click here.
For more information on PDA's technical reports, click here.

About PDA – Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organisation, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its 10,000 members worldwide.

Thomas Peither is currently taking part in the PDA'S Annual Conference. We will cover the highlights of the PDA Meeting in one of our upcoming Logfiles.

Source: Press Release, PDA


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