ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/5721/03
Published01/06/2005
Effective from01/06/2005
KeywordsManufacturing, process changes, comparability, biotechnological products, biological products, recombinant proteins
DescriptionThis document provides principles for assessing the comparability of biotechnological or biological products before and after changes are made in the manufacturing process for the drug substance or drug product. It aims to assist in the collection of relevant technical information which serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product.


Document history

First version

Current version

Adopted guideline

In operation: 01/06/2005–present

Superseded document

Adopted guideline


Concept paper

In operation: 01/12/2003–31/05/2005


Published: 24/06/1998


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