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

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, has announced it has developed a template to help manufacturers and customers comply with U.S. 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 (FDA). 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 Pharmaceutical. “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 U.S. 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 manufacturing practices of APIs, visit: www.socma.com/bptf.