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The ASQ Certified Pharmaceutical GMP Professional Handbook, Third Edition
The ASQ Certified Pharmaceutical GMP Professional Handbook, Third Edition

The ASQ Certified Pharmaceutical GMP Professional Handbook, Third Edition

Mark Allen Durivage

Hardcover, 614 pages, Published 2024
Dimensions: 7x10 inches
ISBN: 9781636941493
Item Number: H1634

Member Price: $105.00

List Price: $150.00
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Keywords

  • CPGP
  • certification
  • good manufacturing practices (GMPs)
  • pharmaceuticals
  • biologics
  • active pharmaceutical ingredients (APIs)
  • excipients
  • packaging and labeling operations

Description

­The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the ­field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry. This third edition of the handbook is updated to reflect the 2023 revised CPGP Body of Knowledge (BoK) and reflect current regulatory oversight.

What’s new in this third edition that aligns with the 2023 BoK:

  • In Section II, ­five new subtopics were added: Risk assessment (II.C.2), Training effectiveness and role of supervisor (II.D.3), Change implementation (II.E.2), Quality agreements (II.K.4), and Outsource processes (II.K.5).
  • In Section VI, one new subtopic was added: Process operations (VI.B.2).
  • In Section VII, one new subtopic was added: Unlabeled product (VII.E.10).
  • New content that addresses hosting in-person and remote evaluations, as well as digital reporting.

Mark Allen Durivage, CRE, CQE, CQA, CSQP, CSSBB, RAC (Global), and CTBS, has worked as a practitioner, educator, and consultant. He is Managing Principal Consultant at Quality Systems Compliance LLC, ASQ Fellow, SRE Fellow, and an Expert Faculty Member for AAMI. Durivage has written several books available through Quality Press and has published articles in Quality Progress and Life Science Connect.