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