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

Current effective version

ICH: Q 5 E: Comparability of biotechnological/biological products - Step 5

AdoptedReference Number: CPMP/ICH/5721/03Legal effective date: 01/06/2005

Document history - First version (current)

ICH: Q 5 E: Comparability of biotechnological/biological products - Step 5

AdoptedReference Number: CPMP/ICH/5721/03Legal effective date: 01/06/2005

Superseded documents

Concept paper on the development of a committee proprietary products (CPMP) guideline of comparability of Biotechnology-derived products

Reference Number: CPMP/BWP/1113/98

Comparability of medicinal products containing biotechnology-derived proteins as active substance - quality issues (Superseded by ICH Q.5.E - CPMP/ICH/5721/03)

AdoptedReference Number: CPMP/BWP/3207/00 Rev.1Legal effective date: 11/12/2003