Der Artikel wurde erfolgreich hinzugefügt.

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

Enter the first customer review for this item

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

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.

Customer reviews will be activated after verification.
Write a customer review

Please enter these characters in the following text field.

The fields marked with * are required.

  • Manufacturers of sterile and aseptic pharmaceuticals
  • Quality assurance
  • Production
  • External service providers
  • Consultants


Technical Requirements

This file is in PDF format!
Filesize: 3,13 MB

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

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.



With this GMP newsletter you will be regularly informed on the latest developments in GMP.

Sign up