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EMA News – QbD: New EMA Guideline on Manufacture of the finished Dosage Form

QbD: New EMA Guideline on Manufacture of the finished Dosage Form

The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document.

This guideline will update the previous guideline “Note for Guidance on Manufacture of the Finished Dosage Form” that was originally adopted in September 1995 and came into operation in 1st April 1996. Since then, the references to directives and format of dossier has been changed, new guidance (i.e. ICH Q8(2), Q9(3), Q10(4)) has been developed. Also the manufacture of finished dosage form has spread worldwide and terms like holding time and bulk product are now important part of the description of manufacturing process. The guideline therefore needs to be revised to be in line with all these changes.

EMA Guideline on “Manufacture of the finished dosage”.

ECA article on EMA Guideline “Manufacture of finished dosage form”