EXCiPACT

To achieve their sustainability ambitions excipient users need to access excipients produced with lower embedded GHG emissions, little or no waste produced and with minimal impact on water quality and availability. As such, in the short-term excipient producers need to optimise processes and switch to renewable or low carbon sources of energy. To achieve the long-term ambitions of the pharmaceutical sector, excipient users and suppliers need to collaborate and share data to identify ways to make step change improvements and identify ways to deliver net zero ingredients within the confines of current legislation.

There has always been a regulatory requirement for Pharmaceutical manufacturers to audit their starting material suppliers, but with increasing and sustained use of 3rd party audit solutions, pharmaceutical manufacturers will need to qualify not only the excipient manufacturer but also the 3rd party certification scheme owner and any associated organisations that perform the audits. The use of the new IPEC GMP Certification Scheme Certification Body Qualification Guide by EXCiPACT is used to explain an efficient means of qualifying these organisations.

The importance of excipients and their specialised role in formulation development has been recognised in recent years, whether that be for targeting delivery of the drug, aesthetics of the final formulation, or shelf life of the final drug product. Some excipients play a simple role in drug formulations while others require an excipient with different properties to perform their job properly.