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GUIDANCE DOCUMENT

Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms September 2007

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
2003N-0528
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The former regulations at 21 CFR 600.11(e)(3) (§ 600.11(e)(3)) required that all work with spore-bearing microorganisms (spore-formers) be conducted in an entirely separate building, or in a completely walled-off portion of a multiproduct building. This isolated building had to be dedicated exclusively for the manufacturing or storage of spore-formers.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2003N-0528.

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