GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates

This book offers understandable introductions to the GMP technical basics and concepts for validation & qualification of projects in the areas of Pharma / Biotech / ATMP / Medical Device.The necessary specialist knowledge about GMP guidelines (validation/qualification/documentation) was made easily and understandably accessible via example and simulated projects.Topics in this book are: What is qualification, and what is validation? Why am I qualifying? How do I start with a GMP concept/project? What are my GMP qualification strategies? How do I write a project risk analysis? What is change control (CC) and do I need a master or sub CC? How do I write a Validation Master Plan (VMP)? What is an FMEA, and why do I need an FMEA? How do I write an FMEA? How do I write a qualification plan (QP)? What are FAT & SAT? And do I need these tests? How do I create qualification documents (DQ, IQ, OQ, PQ)? Step-by-step validation and qualification using case studies