Module 3 2019

When are specifications set or updated?

First Specification set prior to use for first administration to humans Relevance of specification is checked regularly throughout development ● May revise an acceptance criterion or add an attribute to an existing specification when required – By new information – By Regulatory feedback – When compound transitions from one phase (clinical or development) into another – e.g. from Phase 2 to Phase 3 – e.g. from R&D to registration New specification may be set when significant change made to synthetic process or drug product

The Organisation for Professionals in Regulatory Affairs