IPEC Europe is pleased to announce the availability of a ‘Best Practices’ document, "Executing a Multicompendial Compliance Strategy for Pharmaceutical Excipients".
This was developed with the goal of aligning procedures commonly used within companies, to achieve compliance with multiple compendia without performing multiple tests for given excipient attributes.
The approach proposes an eight-step process which can result in one pharmacopoeial test method being selected to represent other pharmacopoeias in scope, without compromising product quality and patient safety.
While similar approaches have been accepted by various stakeholders including regulators, regulations and regulatory guidance will always supersede any company’s effort to employ this process.
In addition to the document itself, IPEC Europe has summarised the methodology in a concise, easy-to-read infographic.