LOGFILE No. 31/2018 – Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing

 03.08.2018

Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing

An excerpt from the new download Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing

5 minutes reading time

by Fritz Röder

The new 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.

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This text is an excerpt from the new download Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing

LOGFILE-31-Comparison-Annex-1-Sterile-Manufacturing.pdf

Author:

Fritz Röder
Degree in Environmental Engineering/Environmental Metrology
Merck KGaA, Darmstadt


The draft of Annex 1 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.

 Order now your copy of Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing!