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Annex 1: What's new? – A Comparison

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The EU GMP Guide Annex 1 on sterile manufacturing of 2008 in comparison to the drafts of 2017 and 2020

Please note that a new version of Annex 1 will be published soon (probably July 2022). The GMP Verlag will then update this edition.



The second draft of February 2020 is the last step towards the final version. Are you already prepared for the changes to come?

Based on a comparison of the currently valid version to the drafts from 2017 and 2020 this download demonstrates where action is needed.

Download (Excel and PDF files)

1 Excel and 1 PDF file, in total 230 pages

ISBN: 978-3-95807-252-7

2nd edition 2020

Delivery immediately after receipt of payment

€99.00 net

€105.93 * prices incl. VAT


The drafts to a new Annex 1 "Sterile and aseptic manufacturing" 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?

This download helps you to answer these questions. The author Fritz Röder has compared the currently valid Annex 1 with the drafts of 2017 and 2020, thus providing an overview and showing where action is needed. A criticality rating of 1-3 marks the various changes.

Even if the drafts are not yet valid, they show in which direction the authorities are thinking. Be prepared for this, as a final version will soon be released.

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.

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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: 4,01 MB

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

The download is password protected to prevent copying and modification of content.

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.
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