In a plan to regulate manufacturing and use of pharmaceutical excipients, Chinese State Food and Drug Administration will publish, by next month, a list defining which excipients must be licensed or require a Drug Master File (DMF) under new quality reglementations due to be introduced. These risk-based assessments will lead to a master list of excipients requiring different levels of regulatory supervision.
“Provinicial SFDA will conduct on-site inspections and random tests according to Excipients GMP (good manufacturing practice).”
The list will specify which registration documents manufacturers will need.
Source : www.in-pharmatechnologist.com Publication Date : 2013-01-22
January 28, 2013