Revised guideline on manufacture of the finished dosage form (Part II)
- 7 December 2017
- bulk, control strategy, CPP, critical process parameter, CTD, design space, finished product, hold time, intermediate, manufacture, process description, RTRT, storage, transport, validation,
On 14 August 2017, the European Medicines Agency (EMA) published revised version of Guideline on manufacture of the finished dosage form. This revised document will become effective on 14 February 2018. We have already informed on our website about a draft of the revised guideline published by the European Medicines Agency (EMA) for public consultation