SOCMA unveils template for drug API custom manufacturers
Joins version for general API manufacturers
Two months after unveiling a standardised quality drug agreement for general manufacturers of active pharmaceutical ingredients (APIs), the Bulk Pharmaceuticals Task Force (BPTF) of the US Society of Chemical Manufacturers and Affiliates (SOCMA) has developed a second template for Custom Manufacturers Organisations (CMOs) to help compliance with US regulatory requirements.
The CMO template provides guidance for drafting agreements relating to the custom manufacture and release of APIs regulated by the US Food and Drug Administration (FDA). In common with the general template, the CMO version is based on the collective experience of industry members.
‘CMOs are getting flooded with customers requesting quality agreements and in many cases customers have different and conflicting agreements which may not be practical or regulatory in nature,’ said BPTF chairman Brant Zell of Cherokee Pharmaceuticals.
‘With today’s supply chain issues and the potential for misunderstandings in a global environment, a quality agreement is the best way to ensure compliance and meet the FDA’s expectations and filing requirements.’
The CMO template, which can serve as a legal binding document, takes into account the main differences between custom manufacturing and routine API manufacturing. Since each project may have different customers and may only be a few batches, using the standardised template is considered essential. However, there is some flexibility in the template to meet individual needs.
BPTF is a trade organisation 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.
