Shoreh Shabrang is senior consultant RA CMC, SAABAS LLC.
Retirement for Obsolete Heavy Metals Tests
This article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
Pharma Collaboration Proposes Retirement of Obsolete Heavy Metals Tests
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.