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.Nature of construction and finishes (C.3.2): A narrative format is preferred for this section. ... Outlines the heating, ventilation, and air conditioning (HVAC) system, areas with different classes of air, pressure differential principles to prevent ... This section describes the planned preventive maintenance program, including written procedures and suitable reporting forms for maintenance and servicing.
|Title||:||The Certified Pharmaceutical GMP Professional Handbook|
|Author||:||Mark Allen Durivage|
|Publisher||:||ASQ Quality Press - 2014-06-05|