EMA: Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form

This concept paper addresses the need to update and revise the CPMP/QWP/486/95 note for guidance on manufacture of the finished dosage form (1). This guideline 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.