Different phrases are used to describe the expectation for evaluation of suppliers of materials [ICH Q7, Sections 7.11, 7.12, 7.31], including traders, if any.
[ICH Q7, Section 7.12] states that all materials are purchased against a specification and from suppliers approved by the quality unit [ICH Q7, Section 7.31]. Prior to approval of any supplier, an evaluation should be conducted using a risk-based approach [ICH Q9, Appendix II.5; ICH Q7, Section 7.31]. More extensive evaluation is needed for suppliers of those materials classified as ‘critical’ [ICH Q7, Section 7.11].
