EMA published a Draft guideline on manufacture of the finished dosage form (Part I)
- 26 August 2015
- bulk, control strategy, CTD, design space, finished product, GDP, intermediate, manufacture, process description, RTRT, storage, transport,
On 9 July 2015, EMA released for 6 months public consultation the Draft guideline on manufacture of the finished dosage form. It should be mentioned here, that the need to update and revise the CPMP/QWP/486/95 note for guidance on manufacture of the finished dosage form (current guideline) was originally presented in the document entitled Concept