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PDA Publishes Pharma. Quality Metrics Definitions in Points to Consider Paper

For Immediate Release:
Media Inquiries:
Walt Morris
/ [email protected] /
301-656-5900, x. 148

The paper is available to the public in the just published Sept/Oct PDA Journal of Pharmaceutical Science and Technology

Bethesda, Md., October 27, 2014 Year – The Parenteral Drug Association (PDA) published definitions for four key quality metrics in an updated version of its “Points to Consider: Pharmaceutical Quality Metrics,” which was first published independently in December 2013. The new version adds the four definitions, which include the recommended methodology to calculate and report each specific metric. The paper published in the just released September/October issue of the PDA Journal of Pharmaceutical Science and Technology ( and is free to the public.

The quality metrics defined are:

  • Product Quality Complaint Rate by Product
  • Batch Reject Rate by Site
  • Confirmed Out-of-Specification Rate by Product and Site
  • Recalls by Product and Site

“The addition of the pharmaceutical quality metric definitions is the culmination of a year-long effort by PDA to assist the industry in responding to FDA’s request for information on the subject,” said PDA President Richard Johnson. “The publication of these definitions is not the end of the process for PDA and the task force of volunteers, as the definitions set the stage for our second workshop on quality metrics in December this year. FDA will co-chair this event, which aims to further the dialogue over FDA’s utilization of robustness and compliance metrics.”

The authors and contributors to the quality metrics points to consider paper are:

  • Steve Mendivil (Amgen)
  • Joyce Bloomfield (Merck)
  • Vince Anicetti (Coherus)
  • Denyse Baker (PDA)
  • Ian Elvins (Consultant)
  • John Farris (Amgen)
  • Gabriele Gori (Novartis)
  • Bob Kieffer (Consultant)
  • Edwin Martinez-Rivera, (Sanofi)
  • Marty Nealey (Hospira)
  • Pritesh Patel (Allergan)
  • Anil Sawant (Johnson & Johnson)
  • Sue Schniepp (Allergy Labs)
  • Anders Vinther (Sanofi)
  • Glenn Wright (Eli Lilly)

Emer Cooke, the Head of International Affairs at the European Medicines Agency, and Janet Woodcock, the Director of the U.S. FDA Center for Drug Evaluation and Research are featured speakers at the 2014 PDA Pharmaceutical Quality Metrics Conference. More information on the workshop can be found at: