Commissioning, Qualification and Validation: A GMP Approach

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)