Description
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
