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Annex 1: What's new? – A Comparison

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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.

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