FDA Guidance for Industry : Manufacturing Biological Intermediates and Biological Drug Substances
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. The Food and Drug Administration (FDA), modified the regulatory requirements for the manufacturing of biological products with spore-formers to allow greater manufacturing flexibility. Under the revised regulation1 they no longer require the use of permanently dedicated buildings and equipment for spore-formers, if certain controls and precautions are applied. They recognize that advances in facility, system, equipment design, testing, and sterilization technologies have increased the ability of manufacturers to control and analyze the manufacture of biological products.
| Published: | 2007 |
| Format: | |
| Length: | 17 pages |
| Type: | White paper |
| Language: | English |
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