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The EU GMP Guide Annex 1 on sterile manufacturing of 2008 in comparison to the drafts of 2017 and 2020
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.
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1 Excel and 1 PDF file, in total 230 pages
2nd edition 2020
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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:
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.
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This file is in PDF format and Microsoft Word ".docx" / Microsoft Excel ".xlsx" format!Filesize: 4,01 MB
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