SOCMA unveils template for drug API quality agreements
Aims to standardise quality agreements for APIs across the pharma industry
In an effort to standardise quality agreements for active pharmaceutical ingredients (API) across the pharma industry, the Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the US Society of Chemical Manufacturers and Affiliates (SOCMA), has developed a template to help compliance with US regulatory requirements.
The 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 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 manufacturers and customers both win by using a harmonised 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 said.
The BPTF plans to unveil a quality agreement template for contract manufacturers of APIs next month (May).
The trade organisation is for US manufacturers of APIs, their intermediates and excipients. Created in 2002 as an affiliate 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.