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

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

Parviz Bayegi

303,76 €
IVA incluido
Disponible
Editorial:
Lulu Press
Año de edición:
2023
Materia
Farmacología
ISBN:
9781447855101
303,76 €
IVA incluido
Disponible
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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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