API producers develop quality agreement template

Lactose powderIndustry organisation the Bulk Pharmaceuticals Task Force (BPTF) has developed a template for quality agreements between active pharmaceutical ingredient (API) suppliers and their customers.

The development comes at a time when pharmaceutical manufacturers are increasingly asking for quality assurance agreements to meet US Food and Drug Administration (FDA) standards, says the BPTF, which is an affiliate of the Society of Chemical Manufacturers and Affiliates.

In part that is a reflection of increased nervousness on the part of industry on the issue of API quality, given recent scandals such as the adulteration of heparin API by suppliers in China.

The template (downloadable here) is designed to provide a standard approach to these quality agreements, says BPTF, and to prevent API suppliers having to handle varied and sometimes conflicting requirements from their customers.

BPTF says it also plans to unveil a quality agreement template for contract manufacturers of API next month.

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