In order to standardize quality agreements for pharmaceutical ingredients active in the pharmaceutical industry, the Bulk Pharmaceuticals Task Force, a subsidiary of the Society of Chemical Manufacturers and Affiliates, has developed a model that helps manufacturers and customers meet U.S. regulatory requirements in a simplified way. The Model Quality Agreement is intended to serve as a guide for the development of agreements on the manufacture and release of drugs regulated by the U.S. Food and Drug Administration. The bill is based on the collective experiences of industry members, according to a SOCMA press release. BPTF plans to unveil a quality agreement template for API contract manufacturers later this month. “Manufacturers of active pharmaceutical ingredients are inundated with customers seeking quality agreements to meet FDA requirements,” Brant Zell, president of the BPTF at Cherokee Pharmaceuticals (Riverside, PA) said in the SOCMA press release. “In many cases, customers have different and conflicting requirements that may not be practical or regulatory in nature, making the process both lengthy and a recipe for error in the API`s manufacturing quality system,” he said. Zell added that manufacturers and customers benefit from a harmonized quality agreement.
“The API manufacturer can be efficient and customers can be sure that all activities covered by the agreement would meet regulatory expectations,” he explained. . . * BPTF is an industry trade organization for U.S. manufacturers of active pharmaceutical ingredients, their intermediates, and excipients. Founded in 2002 as a subsidiary of SOCMA (Society of Chemical Manufacturers and Affiliates), its main purpose is to seek clarification on current regulatory requirements and to interact with government agencies on emerging issues that may affect SOCMA members. . .