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