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SOCMA's Bulk Pharmaceuticals Task Force Unveils Template for Drug API Quality Agreements

FOR IMMEDIATE RELEASE 
April 29, 2010

Media Contact:
Christine Sanchez
Manager, Public Relations & Media            
(202) 721-4182
sanchezc@socma.com

Washington, DC – In an effort to standardize quality agreements for active pharmaceutical ingredients (API) across the drug industry, the Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), today announced it has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

The
quality agreement template was created to provide guidance for drafting agreements relating to the manufacture and release of drug substances regulated by the Food and Drug Administration. The template is based on the collective experience of industry members.

“Manufacturers of active pharmaceutical ingredients are getting inundated with customers requesting quality agreements to meet FDA requirements,” said BPTF Chairman Brant Zell of Cherokee Pharmaceuticals LLC.  “In many cases, customers have different and conflicting requirements, which may not be practical or regulatory in nature, making the process both time consuming and a recipe for failure inside the API manufacturing quality system.”

Zell added that both manufacturers and customers win by using a harmonized quality agreement.   “The API manufacturer can be efficient and customers can be assured that all the activities covered in the agreement would meet regulatory expectations,” he explained.

BPTF also plans to unveil a quality agreement template for contract manufacturers of API next month.

BPTF is an industry trade organization for US manufacturers of active pharmaceutical ingredients, their intermediates and excipients.  Created in 2002 as an affiliate organization of SOCMA, its primary objective is to seek clarification of current regulatory requirements and to interact with governmental agencies on emerging issues that may impact SOCMA members.

For more information on this, or any other topic relating to current good manufacturing practices of APIs, please visit:
www.socma.com/bptf.

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About SOCMA
SOCMA is the leading trade association serving the batch, custom and specialty chemical industry since 1921. SOCMA’s nearly 300 members employ more than 100,000 workers across the country and produce 50,000 products valued at $60 billion annually. For more information please visit www.socma.com.
 
ChemStewards® is SOCMA’s flagship environmental, health, safety and security (EHS&S) continuous performance improvement program.  ChemStewards® was created from industry’s commitment to reducing our environmental footprint.  Industry created ChemStewards® to meet the unique needs of the batch, custom, and specialty chemical industry. As a mandatory requirement for SOCMA members engaged in the manufacturing or handling of chemicals, ChemStewards® is helping participants reach for superior EHS&S performance.  To learn more visit www.chemstewards.com.


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