Deconstructing the revised EMA guideline on manufacture of the finished dosage form

Source: Regulatory Rapporteur – Vol 14, No 9, September 2018
Authors: Tessa Fiorini Cohen, Claire Corinne Azzopardi, Michelle Gafa

A recently published Regulatory Rapporteur article from our sister company Real Generics Ltd, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising the main differences and reviewing stakeholder comments received by the EMA during the associated consultation period.

Please view the full article attached herein.

RR September 2018 Cohen et al CMC article HR (002)