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

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The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the pharmaceutical industry busy. Are you already prepared for the possible changes? Based on a comparison with the currently valid version this download demonstrates where action is needed.

Download (Word, Excel, PDF files)

1 PDF, 1 Microsoft Word, 1 Microsoft Excel file, in total 251 pages

ISBN: 978-3-95807-121-6

1st edition 2018

Delivery immediately after receipt of payment

€97.00 net

€115.43 * prices incl. VAT

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The 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, 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
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