SOURCE: Parenteral Drug Association (PDA)

September 12, 2007 13:19 ET

PDA Revised Technical Report on Cold Medicinal Products Shipping Takes Global View; Training on the Document to Occur in Germany in October, Ireland in November

BETHESDA, MD--(Marketwire - September 12, 2007) - The Parenteral Drug Association (PDA) (http://www.pda.org) has published Technical Report No. 39 (Revised 2007), "Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment," updating a 2005 version of the document. The new version broadens the global applicability of the document by harmonizing with both the regulatory requirements of the US Food and Drug Administration (FDA) and the EU's European Medicines Agency (EMEA).

"Technical Report No. 39 was a landmark document for PDA, as it introduced best practices for controlled temperature shipping to our membership and the industry at large," says PDA President Bob Myers. "The updated version expands the document's applicability globally by harmonizing with the expectations of EU regulators."

The rewrite was prepared by the PDA Temperature-Controlled Pharmaceuticals Group -- Harmonization Task Force, a panel of experts from the pharmaceutical industry with significant experience manufacturing and shipping temperature-sensitive products. The members of this international group are:

Rafik Bishara, PhD, Eli Lilly and Company (chair)
Detlef Dicthe, Eli Lilly and Company
Shirley-Ann Feld, Sanofi-Aventis
Janne Grusgaard, Novo Nordisk
David Patrick, Johnson & Johnson
Bob Seevers, PhD, Eli Lilly and Company
Edward Smith, PhD, Wyeth
David Ulrich, Abbott Laboratories
Wigand Weirich, PhD, Roche
Karl Womastek, Baxter

Members of the task force will be participating in training workshops and lecture courses in the coming months. A "Pharmaceutical Cold Chain Management" conference will take place in Berlin, October 17-18, following a more detailed lecture course October 15-16. A second lecture course on Technical Report No. 39 will occur in Cork Ireland, November 15-16. Courses and a conference on the document are planned for the United States, March 11-14. A copy of the technical report will be given to attendees of the conferences and training sessions.

The document and the training will benefit both manufacturers of temperature-sensitive products and the companies that ship such products.

About PDA Technical Reports

PDA Technical Reports are drafted by all-volunteer task forces sanctioned by the Association's volunteer advisory boards and Board of Directors. These reports are intended for regulator and industry guidance on scientific and operational subjects pertaining to the pharmaceutical and biopharmaceutical industry. Over 40 titles are currently available in PDA's library of technical reports. All can be purchased at www.pda.org/bookstore. When first published, technical reports are distributed to the PDA membership and subscribers to the PDA Journal of Pharmaceutical Science and Technology.

About PDA

Connecting People, Science and Regulation®

The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.

About the PDA Journal of Pharmaceutical Science and Technology

The PDA Journal of Pharmaceutical Science and Technology (The Journal), established in 1946, is considered to be one of the most relevant and highly cited vehicles for peer-reviewed scientific and technical papers in the pharmaceutical and biopharmaceutical industries. The Journal is published bimonthly and is distributed to the PDA membership as a member benefit. The Journal is also available by subscription to industrial, university, and public libraries, as well as to government agencies.

Contact Information

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    PDA Global Headquarters
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