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  4. Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability
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GUIDANCE DOCUMENT

Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability September 1998

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1997-D-0098
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is publishing a guidance entitled ‘‘Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The document provides broad guidance on appropriate standards for the derivation and characterization of cell substrates used in the production of biotechnological/biological products and recommends information in these areas that should be presented in marketing applications.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1997-D-0098.

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