1/2 December 2020
According to the EMA, the currently available documents on the selection of suitable sterilisation processes have become obsolete since in the meantime essential items have been developed in more recent documents (like ICH Q8). The EMA has therefore proposed to withdraw the Guideline CPMP/QWP/155/96 "Note for Guidance on Development Pharmaceutics" and to develop a new guideline instead which describes the decision tree for the selection of sterilisation methods. The latter is currently available as annex (CPMP(QWP/054(98) of the guideline named. The new document should apply to human and veterinary medicinal products. At the moment, there has been no planned proposal to withdraw the veterinary development pharmaceutics guideline (EMEA/CVMP/315/98) as the ICH documents don't include veterinary medicinal products within their scopes.
Among other things, the following aspects should be taken into consideration:
In the next three months, the Quality Working Party in charge of the document will be collecting all comments to this concept paper. After that, they will publish a guideline which - in turn - will undergo a 6-month consultation period.
Please also see EMA's concept paper "Establishment of a guideline on the selection of sterilisation processes for drug products".