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

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

BETHESDA, Md., Oct. 27, 2014 /PRNewswire-USNewswire/ -- 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)

- Edwin Martinez-Rivera, (Sanofi)

- Joyce Bloomfield (Merck)

- Marty Nealey (Hospira)

- Vince Anicetti (Coherus)

- Pritesh Patel (Allergan)

- Denyse Baker (PDA)

- Anil Sawant (Johnson & Johnson)

- Ian Elvins (Consultant)

- Sue Schniepp (Allergy Labs)

- John Farris (Amgen)

- Anders Vinther (Sanofi)

- Gabriele Gori (Novartis)

- Glenn Wright (Eli Lilly)

- Bob Kieffer (Consultant)

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:

About PDA C 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 organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its almost 10,000 members worldwide. Go to to learn more.

Media Inquiries: Walt Morris, 301-656-5900, x. 148;

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Publication:PR Newswire
Date:Oct 27, 2014
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