EMA published a Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (Part I)
- 29 июня 2016
- API, GMP, SAL,
On 13 April 2016, EMA released for 6 months public consultation the Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. A new guidance is developed as a separate guidance document and will replace Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98) and Decision trees for the selection