Rx-360 Summary of EMA Guideline on Health Based Exposure Limited in Shared Facilities
The objective of this guideline is to recommend an approach to review and evaluate pharmacological and toxicological data of individual active substances, enabling the determination of threshold levels as referred to in the GMP guideline. These levels can be used as a risk identification tool, and can also be used to justify carry over limits used in cleaning validation. This guideline should be read in conjunction with EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, Chapter 3 and 5.
This final guideline has been developed as a risk identification tool to facilitate the implementation of a science and risk based approach to manufacture of medicinal products using shared manufacturing facilities in accordance with Chapters 3 and 5.
To view or download the EMA Guidance, click here
To view or download the Rx-360 Summary of the Guidance, click here
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