|
The first major attempt by the government to control the operation of the nation's pharmaceutical manufacturers occurred with the release of original regulations (21CFR-210, 211) governing the manufacture and control of pharmaceutical products. These regulations were specially issued to address current Good Manufacturing Practices (cGMPs) within the industry.
Industry practice concerning the design and construction of API facilities is to use the Baseline® Pharmaceutical Engineering Guides, issued jointly by the ISPE and the FDA, as appropriate. While these guides are not meant to replace existing laws or regulations that apply to facilities of this type, they do present a consistent interpretation and approach to facility design, construction, commissioning, and validation.
|
