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

Regulatory Resource: Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in November 2004. 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. Therefore, this guideline is intended 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. The document does not prescribe any particular analytical, nonclinical or clinical strategy. The main emphasis of the document is on quality aspects.

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