The Certified Pharmaceutical GMP Professional Handbook

The Certified Pharmaceutical GMP Professional Handbook

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The purpose of this handbook is to highlight and partially annotate what the founders of the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination believed to be the main topics comprising worldwide pharmaceutical good manufacturing practices (GMP). The topics in the body of knowledge (BOK) of this ASQ certification cover compliance with GMPs, as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals where regulated as drug products), as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients) and packaging and labeling operations.Corrective and preventive action (CAPA) is an absolute that defines the backbone of the quality management system (QMS). The systemic management of the CAPA program is an expectation of most standards and regulations (for example, anbsp;...


Title:The Certified Pharmaceutical GMP Professional Handbook
Author: Mark Allen Durivage
Publisher:ASQ Quality Press - 2014-06-05
ISBN-13:

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