The application of EXCiPACT’s GMP Standard to Pharmaceutical Auxiliary Materials (PAMs)

Synopsis

EXCiPACT is extending its certification scheme to PAMs and is developing a guide for manufacturers and auditors.

As PAMs may be in intimate contact with a material which will be administered to patients, they should be manufactured in accordance with GMP principles. Typically, PAMs are removed before use in the manufacture of a drug product or function as processing aids in the manufacture of the excipient.

Although the manufacturing processes used for PAMs may not be traditional chemical manufacturing processes, applying the risk-based approach in EXCiPACT GMP means this standard can be applied to PAMs. The guide will help manufacturers apply EXCiPACT GMP to the preparation and distribution of PAMs and as well as supporting auditors when assessing compliance for certification purposes.