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Inspection of Process Validation

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Do your validation processes meet their specified requirements? This bilingual guide offers an excellent up-to-date approach on process validation. It facilitates the planning and execution of all necessary steps to be compliant.

e-book

90 Seiten

ISBN: 978-3-95807-120-9

1st edition 2018

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59,00 € netto

61,95 € * inkl. gesetzlicher MwSt.

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Techn. Voraussetzungen

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What should validation documentation contain?
How does one implement continued process verification?
What is the role of risk management?
What receives particular attention during an inspection?

In this GMP Series e-book you will be given specific answers to these and other frequently asked questions.

The validation of processes is a primary requirement in the pharmaceutical industry. This Aide-Mémoire of ZLG is a structured guide for the planning and execution of process validation. New concepts for modern process validation are introduced and known facts are summarised.

Due to its importance for the pharmaceutical industry, the directive document was translated into English by the Maas & Peither AG, GMP-Publishing. With this volume, you receive a bilingual comparison with excellent practical applicability, also in an international context.

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Persons who are responsible for the validation of processes in the areas of quality management, quality assurance, quality control and production
Engineering
Persons who are responsible for process validation documents
Suppliers of the pharmaceutical and active ingredients manufacturing industry

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Technical Requirements

This file is in PDF format!
Filesize: 2,27 MB

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The e-book is password protected to prevent copying and modification of content.

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