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GMP Fundamentals – A Step-by-Step Guide (book)

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A helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.

Available as book and e-book

Softcover

130 pages

ISBN: 978-3-95807-105-6

second edition 2018

plus shipping and handling

Delivery time appr. 2-3 workdays

Quantity Unit price netto Unit price incl. VAT
To 9 €39.90 €42.69
From 10 €34.90 €37.34
From 50 €29.90 €31.99
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This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previously acquired knowledge.

Some topics are:

  • GMP: Purpose and basic pharmaceutical terms
  • Laws, licenses and inspections
  • Personnel: responsibility and hygiene
  • Standard Operating Procedures (SOP) and documentation
  • Design of rooms and facilities
  • Processing and packaging
  • Quality control and market release
  • Suppliers, storage and logistics (Good Distribution Practice = GDP)
  • Alphabetical index and abbreviations

Using practical examples and comparisons to every-day life will help to easy understand GMP regulations.

GMP Fundamentals is a helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.

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From Daniel Trummer On 16.05.2020

Perfekt für den Pharma-Neuling: so einfach wie möglich, so detailliert wie nötig

Meine Berufserfahrung ist von anderen Branchen. Viele der Konzepte in diesem Buch sind zumindest ansatzweise auch in diesen Branchen relevant. In der Pharma-Branche ist alles einige Stufen strenger und umfassender. Die Information im Buch ist von A bis Z zugänglich, strukturiert und verlinkt, dabei umfassend, ohne sich je zu verlieren. Äusserst lehrreich auch für andere Branchen, und sogar für das Privatleben (speziell in Corona-Zeiten).

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Beginner to Advanced Level and Beyond

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Previous editions of GMP Fundamentals:

1st edition 2015 | ISBN: 978-3-95807-006-6

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