£182.64

GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates: for Pharma / Biotech / ATMP / Medical Device

Pharmacy - Dispensing

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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

Product Specifications

Format: Paperback
ASIN: 1447855108
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 07 February 2023
Listed Since: 10 February 2023

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GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates: for Pharma / Biotech / ATMP / Medical Device

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