CRED Getting the CMC Dossier Right 2024

EDQM

PA/PH/CEP (04) 1 7R

Certification of Substances Department

ICH Q11 Q&A Questions and Answers: selection and justification of starting materials for the manufacture of drug substances EMA/CHMP/CVMP/QWP/586330/2010 Questions and answers on post approval change management protocols

WHO Technical Report Series No. 1010, 2018

Annex 10: WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products

Page 19 of 19