EXCiPACT Guide on Application of EXCiPACT GMP Standard to PAM (Pharmaceutical Auxiliary Materials)
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.
They are not intentionally included in the final product and so not administered to the patient. As residual levels may remain in the medicinal product, API or drug substances, PAMs may need to be manufactured in accordance with GMP principles, including the avoidance of contamination.
Manufacturing processes used for PAMs may not follow traditional chemical manufacturing processes, so hazards to product integrity and quality could be different. The risk-based approach underpinning EXCiPACT GMP for pharmaceutical excipients can be applied to provide an appropriate and proportionate GMP for these materials.
The quality oversight of PAMs is a challenge for many in the pharmaceutical sector and EXCiPACT’s GMP standards can play a role here. This guide (available here) has been prepared by experts to provide advice on how EXCiPACT GMP can be applied to the manufacture of PAMs. With this guide, the EXCiPACT Certification process can deliver GMP Certificates specifically adapted to Pharmaceutical Auxiliary Materials. It is also intended as supplemental information for auditors of PAM manufacturers to assess compliance to the EXCiPACT GMP.
EXCiPACT launched this programme on 23 May 2023. If you are interested on how the scheme for PAMs will work and how your organisation can be EXCiPACT-certified for PAMS, please contact firstname.lastname@example.org.
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