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.Site plan and manufacturing areas (C.3.1): Provides a site plan highlighting the production areas, and a simple plan of each production area with indication of scale. For sterile ... Description of planned preventive maintenance program and recording system (C.3.6): aMaintenancea is done by the ... For specific pieces of machinery (for example, a rotary tablet press), only a general description is required.
|Title||:||The Certified Pharmaceutical GMP Professional Handbook|
|Author||:||Mark Allen Durivage|
|Publisher||:||ASQ Quality Press - 2014-06-05|