Manufacturing
Abstract
Manufacturing of TE/RM products needs to take place in a tightly controlled and qualified environment. As with any activity under regulatory agency scrutiny, building and maintaining such an environment requires a substantial investment in construction, personnel and infrastructure. Proper planning and development are critical to containing costs. In this chapter, key aspects of the planning and development stages, as well as regulatory requirements for maintaining a GMP-compliant facility, are considered.
Keywords
GMP manufacturing
HVAC system
ISO classifications
critical areas
validation
qualification
raw materials
bill of materials
10.1 Facility considerations
The regulatory requirements placed upon the biotechnology ...
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