10

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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