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Description
GMP Compliance at Validation, Qualification & Documentation with practical case studies and templatesThis 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?
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
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