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GUIDANCE DOCUMENT

Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process June 2005

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2004-D-0440
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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 guidance is intended to assist manufacturers of biotechnological/biological products in the collection of relevant technical information that 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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All written comments should be identified with this document's docket number: FDA-2004-D-0440.

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