ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products - Scientific guideline
This 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.
Keywords: Manufacturing, process changes, comparability, biotechnological products, biological products, recombinant proteins
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Concept paper on the development of a committee proprietary products (CPMP) guideline of comparability of Biotechnology-derived products (PDF/27.68 KB)
First published: 24/06/1998
Last updated: 24/06/1998
CPMP/BWP/1113/98 -
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Comparability of medicinal products containing biotechnology-derived proteins as active substance - quality issues (Superseded by ICH Q.5.E - CPMP/ICH/5721/03) (PDF/195.95 KB)
Adopted
First published: 11/12/2003
Last updated: 11/12/2003
Legal effective date: 11/12/2003
CPMP/BWP/3207/00 Rev.1