GMP Compliance at Validation, Qualificatio...

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Sprache: Englisch

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Beschreibung

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

Details

Erscheinungsjahr:	2023
Fachbereich:	Andere Fachgebiete
Genre:	Importe , Medizin
Rubrik:	Wissenschaften
Medium:	Taschenbuch
Inhalt:	Kartoniert / Broschiert
ISBN-13:	9781447855101
ISBN-10:	1447855108
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Autor:	Bayegi, Parviz
Hersteller:	Lulu.com
Verantwortliche Person für die EU:	Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de
Maße:	254 x 178 x 12 mm
Von/Mit:	Parviz Bayegi
Erscheinungsdatum:	07.02.2023
Gewicht:	0,427 kg