SOCMA Issues API Quality-Agreement Template

May 13, 2010
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

In an effort to standardize quality agreements for active pharmaceutical ingredients (APIs) in the drug industry, the Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner. SOCMA announced the development of a quality-agreement template late last month. SOCMA is the US-based trade organization representing batch and custom manufacturers, including contract API manufacturers.

The quality-agreement template is intended to provide guidance for drafting agreements relating to the manufacture and release of drug substances regulated by the US Food and Drug Administration. The template is based on the collective experience of industry members, according to a SOCMA press release.

“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 (Riverside, PA), in the SOCMA press release. “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,” he said. Zell added that manufacturers and customers benefit 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 plans to unveil a quality-agreement template for contract manufacturers of APIs later this month.