Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook

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With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing. Quality Systems Approach According to the FDA staff manual guide [53], a quality system is a a€œset ... Based on this description, PAT should be considered to be an important tool for supporting a quality management system.As statedanbsp;...

Title:Pharmaceutical Manufacturing Handbook
Author:Shayne Cox Gad
Publisher:John Wiley & Sons - 2008-04-04


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