EU Excipient Risk Assessment Guidelines

The Challenges of Determining Excipient Quality

In the past years, the critical role of excipients in drug production has come into focus.

This meant shaking off the long prevailing perception of excipients being passive additions to an active pharmaceutical ingredient (API). Now regulatory authorities are calling for more stringent quality management in excipient production and use, leading to new requirements for both excipient suppliers and drug manufacturers. Regulating excipient quality, however, is no small task.

More than one thousand different excipients are available, and only a small number of them are manufactured solely for pharmaceutical use. This heterogeneity and the resulting complexity have led to the EU Commission’s approach to excipient quality. It is clearly risk-based; its core consists of general guidelines that offer a framework for excipient risk assessment.

However, the guidelines provide neither detailed instructions for implementation nor a clear definition of appropriate Good Manufacturing Practices (GMP) for excipients. This is the responsibility of the manufacturing authorization holder – and evidently no small task either. Readers of this white paper will find support in mastering the challenge of formalized excipient risk assessment.

They will gain an overview of the relevant laws and guidelines, as well as voluntary standards developed by the industry to foster implementation. Most importantly, a case study on excipient risk assessment will provide valuable insights into risk assessment and preparing for inspections.
Download the full whitepaper here: Excipient-Risk-Assessment