Different phrases are used to describe the expectation for evaluation of suppliers of materials [ICH Q7, 7.11, 7.12, 7.31], including traders, if any. [ICH Q7, 7.12] states that all materials are purchased against a specification and from suppliers approved by the quality unit [ICH Q7, 7.31]. Prior to approval of any supplier, an evaluation should be conducted using a riskbased approach [ICH Q9, Appendix II.5; ICH Q7, 7.31]. More extensive evaluation is needed for suppliers of those materials classified as ‘critical’ [ICH Q7, 7.11].
What is meant by ‘full analysis’ [ICH Q7, 7.31] on batches of raw materials to qualify a supplier?
A ‘full analysis’ should include all tests specified by the user of the raw material in the regulatory filing. In cases where no filing is required, the full analysis should include tests in other formal written specifications issued by the user of the raw material [ICH Q7, 7.31]. A raw material supplier’s Certificate of Analysis (CoA) may not necessarily align with the user’s specifications.
Are on-site audits required in the evaluation of suppliers?
No. An on-site audit is not required; however, an on-site audit could be a useful tool in the evaluation of a supplier. A risk assessment of the material or the service provided can be used to develop an audit strategy and manage the ongoing evaluation of suppliers [ICH Q7, 7.11, 7.31].
No comments:
Post a Comment