ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

Title:
ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

https://www.gmp-compliance.org/files/guidemgr/Q5E.pdf

Origin/Publisher:

Document Type:
ICH Guideline
Content:
The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product.

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