Guidance for Industry. Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microoganisms

摘要

The former regulations at 21 CFR 600.11(e)(3) (SC 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. Previously, areas in a multiproduct building used for manufacturing with spore-formers were required to be constructed to prevent cross-contamination of other areas, and were required to include entrances that were separate and independent from the remainder of the facility. All equipment used for manufacturing spore-formers was to be permanently identified and reserved exclusively for use with those microorganisms. Any materials destined for further manufacture were to be removed from this area only under conditions that prevented the introduction of spores into other manufacturing areas.