After submitting their individual comments on the targeted consultation of the European Commission’s good manufacturing practice guideline’s Annex I for sterile drug products, representatives of 12 industry associations in Europe thought it would be a good idea to band together and develop a unified set of “high level” recommendations to improve the annex.
Final Revisions Should Ease Global Use Of EU GMP Annex I Sterile Drugs Guidance, Associations Say
Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.
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