GMP Compliance at Validation, Qualification & Documentation With Practical Case Studies and Templates For Pharma / Biotech / ATMP / Medical Device

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