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Application of EXCiPACT’s GMP Standard To Pharmaceutical Auxiliary Materials - A Guide for manufacturers and auditors

Pharmaceutical Auxiliary Materials (PAMs) are materials used in processes to make medicinal products, active pharmaceutical ingredients (APIs) and drug substances. PAMs include for example inert gases, processing aids and, in biotechnology-led manufacturing, cell culture media.

In case you missed this recent posting on LinkedIn, we would like to formally introduce you to the EXCiPACT Management Body duly elected at the 2023 Annual General Assembly.

Kevin McGlue (Treasurer) of course, is already well known to you but please join me in welcoming Morad Amadji (President), Jessica Cansler and Shine Gao (Vice president) as new administrators of EXCiPACT.  We look forward to many fruitful collaborations and successes in the future!

Equally, our sincere thanks and gratitude to the outgoing representatives, Iain Moore, David Klug, and Bree Wang whose contributions to EXCiPACT have been so important.

US FDA Warning Letter related to excipients produced by DuPont at 1301 Ogletown Rd, Newark, DE 19711, United States.

 

US FDA WARNING LETTER DuPont Nutrition USA Inc. MARCS-CMS 627211 DECEMBER 02, 2022

 

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