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Quality Management

Essentials of Technical Documentation for Drug Manufacturing
€ 87.00
€ 103.53
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
pdf download
Excerpt from the GMP Compliance Adviser
Edition: First edition, 03/2016
17 Pages
ISBN: 978-3-95807-043-1
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

How is technical documentation related to GMP? What are the components of technical documentation in a GMP environment? How is extensive technical documentation managed?

The GMP Publishing management report - Essentials of Technical Documentation for Drug Manufacturing - provides you with the answers. This report will walk you through requirements and their practical, GMP-compliant implementation, including documentation checklists for the mechanical part of a facility as well as for the electrical and control element.

Technical documentation comprises the recording, organisation, and archiving of technically relevant documents and data, as well as making them available for the purpose of providing information. It is used to present processes and technical conditions in a reproducible and up-to-date form. It is important to establish a clearly defined identification and storage system to ensure that the required documents can be accessed as quickly as possible, when required.

With Essentials of Technical Documentation for Drug Manufacturing, you’ll learn everything you need to know on:
  • Requirements for technical documentation
  • GMP-compliant technical documentation
  • Management of technical documentation
  • Log book
Make your technical documentation a top priority — with a report that will ensure your success.

Order your copy today!

Technical Requirements

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  • Technical documentation
  • GMP compliance
  • Quality Assurance
Brandes, Ruven

Ruven Brandes became Head of Technology and Compliance Support for technical QA in 2006. He combines technological expertise with a strong quality awareness and possesses a broad range of professional experience. Mr Brandes is involved in a number of different associations and committees and also works as an author and speaker.

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