The Certified Pharmaceutical GMP Professional Handbook, Second Edition

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight.

This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

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Об авторе (2016)

Mark Allen Durivage has worked as a practitioner, educator, and consultant. Durivage is Managing Principal Consultant at Quality Systems Compliance LLC. He received a B.A.S in Computer Aided Machining from Siena Heights University and a M.S. in Quality Management from Eastern Michigan University. Additionally, Durivage served an apprenticeship and is a journeyman mold maker. He is an American Society for Quality (ASQ) Fellow and holds several ASQ certifications including; CQM/OE, CRE, CQE, CQA, CHA, CBA, CPGP, and CSSBB. Durivage is an active member of the ASQ Toledo Section, ASQ Reliability Division, ASQ Food, Drug, & Cosmetic Division, and Customer-Supplier Division, holding several Section and Division leadership positions. Durivage and his family currently reside in Lambertville, Michigan. He was a contributing author and the editor of The Certified Pharmaceutical GMP Professional Handbook (ASQ Quality Press, 2014), and the author of Practical Engineering, Process, and Reliability Statistics (ASQ Quality Press, 2014), Practical Attribute and Variable Measurement Systems Analysis (MSA), (ASQ Quality Press, 2015), and Practical Design of Experiments (ASQ Quality Press, 2016).

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