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 can be made anonymously and will be published in our webshop 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.

€259.00 net

€87.00 net

  • Aseptic Processing of Sterile Medicinal Products
    A Guide to Aseptic Processing

    €117.00 net

    • 1 named user
    • 3-month-subscription
    • €107 / US$128.40 per month
    • ...

    €321.00 net



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

    Sign up