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Comparison of the EU GMP Guide Annex 1 Version 2008 to Draft 2017 and Draft 2017 to Draft 2020

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Are you already prepared for the possible changes?

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

--- Expected to be available from end of March 2020 ---

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2nd edition 2020

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€97.00 net

€103.79 * prices incl. VAT

The new draft of Annex 1 "Sterile Manufacturing" of the EU GMP Guidelines keeps many responsible persons in the pharmaceutical industry busy.
  • Which aspects are going to change?
  • Am I already prepared for this?
  • What do I have to do now?
This download will help you answer these questions. The author Fritz Röder has compared the currently valid Annex 1 with the draft of 2017 and 2020, thereby providing an excellent overview and pointing out where action is needed. A criticality index of 1-3 evaluates the various changes.

Even if the draft is not valid yet, it shows in which direction the authorities are thinking. You should be prepared for this, as a final version will soon be available.

With the download you receive an extensive MS Excel table, a MS Word file and a PDF document. You can use the download in the format that helps you best.
All files are editable.

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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: 3,13 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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