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The FDA’s GMPs and the EU’s GMPs are supposed to be harmonized. Supposed to be. The reality is there are subtle but significant differences between the two.
And the list goes on. If you think because you passed your last FDA inspection, you’re ready for EU inspectors, you could be sadly mistaken.
This new handbook from FDAnews tells you what you need to know about the similarities — and subtle differences — between FDA and EU GMP inspections.
FDAnews reached out to four authorities on European drug manufacturing quality for their expertise. The result is a handbook you’ll refer to whenever the EU inspectors come to call.
This plain-English guide touches all the bases:
Co-authors represent the state of the art on current good drug manufacturing practices:
With this team of experts at your back, you’ll sail through your next EU drug GMP inspection. So don’t wait.
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