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REGULATORY REQUIREMENTS FOR …
CHAPTER 1 REGULATORY REQUIREMENTS FOR PHARMACEUTICAL PLANTS Introduction When we design a pharmaceutical plant we need to understand and follow the basic REGULATORY REQUIREMENTS for the construction of a pharmaceutical plant. These REQUIREMENTS are mainly divided into two categories namely - REQUIREMENTS related to good manufacturing practices currently followed in pharmaceutical industry . These are elaborately describe in the various international cGMP guidelines. REQUIREMENTS related to Factories Acts and Rules, which is a Central Act and the rules described separately by each state in India, for this work we have referred the rules specified by the state of Maharashtra.
2 | Pharmaceutical Facilities: Design, Layouts and Validation 1.2 Regulatory Requirements Related to Current Good Manufacturing Practices in Pharmaceutical Industry The cGMP requirements are described in …
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