The Parenteral Drug Association (PDA) 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 in Anaheim, California.
“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, PDA says. In addition, the association has a long history of working with other organizations, including the United States Pharmacopiea (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.”
PDA says approval was also granted based upon standards development procedures it 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.