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
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.

Go back