2017/09/22

Golden Biotechnology Corp. Awarded USP GMP Audit Certificate and Meets GMP Requirement in ICH-GMP for Active Pharmaceutical Ingredient (API) on its Dietary Ingredient Manufacturing.

Golden Biotechnology Corp. was awarded the USP Quality System GMP Audited Certificate by USP for its Dietary Ingredient Manufacturing.
Golden Biotechnology Corp. applied for a Good Manufacturing Practice (GMP) audit of its facility under the USP Quality System GMP Audited Verification Program. During the verification process, USP conducted the on-site GMP audits of the manufacturing site. After auditing the facility and the examining the information provided to USP during the GMP auditing process, USP finds that the dietary ingredient manufacturer’s (Golden Biotechnology Corp.) quality system provides sufficient assurance that its site meets the applicable GMP audit requirement set forth in the International Conference on Harmonization Good Manufacturing Practice Guide ( ICH GMP Guide ) for Active Pharmaceutical Ingredient Q 7.

*The GMP audit program builds on USP’s 200 year history protecting public health through public standards for medicines, dietary supplements and food ingredients. USP is the most authoritative source for dietary supplements GMP audits, not only because the United States Pharmacopeia-National Formulary USP-NF is recognized as an official compendia of scientific quality standards for dietary supplements and ingredients, but also because of USP’s leadership specifically in the area of dietary supplement GMPs.

Published in 1993, USP General Chapter <2750> Manufacturing Practices for Dietary Supplements predates both the Dietary Supplement Health and Education Act and the Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs) regulations in 21 Code of Federal Regulations Part 111.

USP has created the GMP audit program in response to overwhelming demand from industry and manufacturers. The Dietary Ingredient and Dietary Supplement Verification Programs are the most comprehensive ways to ensure the quality of a given ingredient or supplement and the GMP audit program is an important addition. It supports USP’s mission by encouraging greater adoption of public standards designed to increase product quality and thereby promotes public health.”

USP’s GMP facility audit program provides assurance that manufacturers not only meet FDA cGMPs, but exceed them. That’s because USP’s GMP audit program is the only program that will require manufacturers to comply with both FDA and USP GMPs.

Efforts by organizations such as USP, a global leader in quality standards, to help dietary supplement companies improve accountability to consumers. Companies will take a serious look at this new initiative and that more and more companies in the industry will seek out ways to promote transparency and demonstrate their commitment to manufacturing and marketing quality products. ( * Reference cited : http://www.usp.org/news/dietary-ingredient-and-supplement-manufacturers-can-demonstrate-superior-quality-systems-using-newly-launched-united-states)