Ph. Eur. Chapter 5.15. Functionality-related characteristics of excipients

Recommendation

9/10 May 2023

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A Draft of Ph. Eur. Chapter 5.15. "Functionality-Related Characteristics of Excipients" has been published in Pharmeuropa 27.4.

The non-mandatory chapter has been completely reviewed to better align with ICH guideline Q8 Pharmaceutical Development. The chapter deals with the critical quality attributes (CQAs) of excipients which are identified during pharmaceutical development work resulting in an excipient quality specification.

It introduces the "quality by design" concept described in the ICH Q8 guideline to excipients which requires a comprehensive understanding of  the way their attributes interact in the formulation and with manufacturing processes.

Additionally, the draft emphasizes a certain degree of regulatory flexibility based on the description of the design space (Life Cycle Management).

The draft is available for comments until 31 December 2015.
 
Following your registration on the Pharmeuropa website you can get to the complete Chapter 5.15. "Functionality-Related Characteristics of Excipients".