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The Road to a Pharmaceutical Quality System

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A step-by-step guide to bring your drug manufacturing systems into compliance!


e-book

38 Seiten

ISBN: 978-3-95807-142-1

1st edition 2019

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87,00 € netto

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Excerpt from the GMP Compliance Adviser

The US FDA and the EU adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board. And the primary objective of a pharmaceutical quality system (PQS) is patient safety.

This e-book helps you bring your drug manufacturing quality systems into compliance.

You’ll discover how to look beyond the multiple silos that so easily develop around individual drugmaking activities. You’ll be ready to implement new problem-solving approaches at every level of your manufacturing operations.

The Road to a Phamaceutical Quality System walks you step by step through the processes and procedures you’ll need to put in place.

Here’s what you’ll learn:

  • What are the key elements of the PQS?
  • What roles do quality policy and quality planning play?
  • What are the responsibilities of management?
  • How are the regulatory requirements implemented in practice?
  • What is the significance of documentation for the PQS?
  • Is a PQS documentation hierarchy necessary (documentation pyramid)?
  • What GMP documentation does a pharmaceutical company need?
  • What is a quality manual and how is it created?
  • Why is a management review carried out and what does it involve?
  • How are suitable key performance indicators defined?
  • What results does a management review deliver and how are they evaluated?

Order now your copy of The Road to a Phamaceutical Quality System!


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