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SOCMA's Bulk Pharmaceuticals Task Forces Develops API Quality Agreement for Custom Manufacturers

Just two months after unveiling a standardized quality drug agreement for general manufacturers of active pharmaceutical ingredients (API), SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) has announced it has developed a second template for Custom Manufacturers Organizations (CMOs) and their customers.

The CMO template was designed to provide guidance for drafting agreements relating to the custom manufacture and release of APIs regulated by the Food and Drug Administration (FDA). Similar to the general template, the CMO version is based on the collective experience of industry members and is meant to fulfill regulatory requirements in a simplified manner.

BPTF chairman Brant Zell of Cherokee Pharmaceuticals LLC says "CMOs are getting flooded with customers requesting quality agreements, and that in many cases customers have different and conflicting agreements which may not be practical or regulatory in nature."

“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 FDA’s expectations and filing requirements,” explained Zell, saying that there is a big advantage for suppliers to keep the same quality and regulatory standards for each customer.

The CMO template, which can serve as a legal binding document, takes into account the main differences in custom manufacturing versus routine API manufacturing. Since each project may have different customers and may only be a few batches, using the standardize template is essential. However, the template does include some flexibility to meet individual drug customers’ needs. 

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 good manufacturing practices of APIs, visit www.socma.com/bptf.

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