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news.Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.
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The quality agreement template was created to provide guidance for drafting agreements relating to the manufacture and release of drug substances regulated by the FDA. The template is based on the collective experience of industry members.
In addition to that BPTF also plans to unveil a quality agreement template for contract manufacturers of active pharmaceutical ingredients (API) next month.
Brant Zell, chairman of BPTF at Cherokee Pharmaceutical, said: “Manufacturers of active pharmaceutical ingredients are getting inundated with customers requesting quality agreements to meet FDA requirements.
“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.
“The API manufacturer can be efficient and customers can be assured that all the activities covered in the agreement would meet regulatory expectations.”