EMA: Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products

This concept paper addresses the need for a revision of the guidance on the selection of sterilisation methods currently provided for in the annexes to the (separate) human and veterinary development pharmaceutics guidelines, that is, CPMP/QWP/054/98 “Annex to development pharmaceutics: Decision trees for selection of sterilisation methods” adopted in 1999 (1), and EMEA/CVMP/065/99-FINAL “Annex to note for guidance: Development pharmaceutics for veterinary medicinal products: Decision trees for the selection of sterilisation methods” (2) adopted in 2000.