Commissioning, Qualification and Validation A GMP Approach
“Commissioning, Qualification and Validation A GMP Approach” by Priscilla Browne is a comprehensive resource published by CreateSpace Independent Publishing Platform in June 2017. This 200-page book is presented in English and addresses the essential requirements of commissioning, qualification, and validation (CQV) within the Life Science industry, specifically focusing on medical device manufacturing, pharmaceuticals, and bio-pharmaceuticals.
Readers will find a structured exploration of the core elements of CQV, including key steps and terminology necessary for successful implementation. The book outlines an integrated approach to CQV, detailing various aspects such as facilities, risk management, validation planning, and supplier validation. Each chapter provides insights into the challenges faced when introducing new facilities, equipment, and processes, making it a valuable guide for professionals in technology and engineering fields related to biomedical applications.
Official synopsis Publisher
Commissioning, Qualification and Validation (CQV) are requirements of modern facilities within the Life Science industry. Be it a Medical Device Manufacturing, pharmaceuticals or bio-pharmaceuticals, each present challenges in how new facilities, equipment, utilities and processes are introduced. Providing a defined approach to CQV aligns activities to ensure success and the timely completion. This book covers the core elements of CQV including the key steps, terminology and how an integrated approach to CQV can be achieved.Chapter 1-Introduction to Commissioning & Qualification (C&Q) Chapter 2-FacilitiesChapter 3-Introduction to Validation Chapter 4-Design RequirementChapter 5-Risk ManagementChapter 6-Validation Planning Chapter 7-Clean UtilitiesChapter 8-Equipment Validation Chapter 9-Process ValidationChapter 10-Test Method ValidationChapter 11-Supplier ValidationChapter 12-Summary of Good Manufacturing Practices (GMP)
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