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Annex 1: What's new? – A Comparison from Draft to Final

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The EU GMP Guideline Annex 1 "Manufacture of sterile medicinal products" in a comparison of the final version from 2022 with the draft version from February 2020.


Are you already prepared for the possible changes?
The comparison shows you where action is needed.


Download (Excel and PDF files)

1 Excel and 1 PDF file, in total 337 pages

ISBN: 978-3-95807-292-3

3rd edition 2022

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The final version of Annex 1 (2022) "Manufacture of Sterile Medicinal Products" of the EU GMP Guide keep many responsible persons busy.

Do you also ask yourself:

  • What is changing?
  • Am I well prepared?
  • What action do I have to take?

Also included in the comparison file are

  • a comparison of the currently still valid version from 2008 with the draft document 2017 as well as
  • a comparison of the draft documents 2017 to 2020.
This makes it easy for you to track all the development steps that led to the final version in 2022. A criticality index from 1 – 3 evaluates the various changes.

With this download you receive this comparison not only as PDF but as an editable MS Excel file, as well. You can use the download in the format that helps you best.

The new Annex 1 for the Manufacture of Sterile Medicinal Products [LOGFILE Feature 32/2022]

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  • Manufacturers of sterile and aseptic pharmaceuticals
  • Quality assurance
  • Production
  • External service providers
  • Consultants

 


Technical Requirements

This file is in PDF format and Microsoft Word ".docx" / Microsoft Excel ".xlsx" format.

Filesize: 5 MB

To view PDF files, we recommend using the Adobe Reader.

https://get.adobe.com/de/reader/

Please note the following procedure guidelines:

For payment by invoice:

  • You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
  • After receipt of payment you will receive an e-mail with the download information.

When paying by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • Your invoice will be sent in a separate e-mail within 1 – 2 working days.

Previous editions:

Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
Version 2008 to Draft 2017
Published in 2018 – ISBN: 978-3-95807-121-6

Annex 1: What‘s new? – A Comparison
The EU GMP Guide Annex 1 on sterile manufacturing of 2008 in comparison to the drafts of 2017 and 2020
Published in 2020 – ISBN: 978-3-95807-252-7

  • An online publication that covers all aspects of Good Manufacturing Practice (GMP) in one...

    €540.00 net

    577.8 - 7.00

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