Issue: Vol. 40

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. This article sets out the standards and guidance for environmental sustainability best practise and information exchange through the pharmaceutical supply chain.

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.