Failures Investigation Sample Clauses
Failures Investigation. Matricel shall investigate any test result or in-process test which fails to meet specification and use [***] to determine the root cause. In case the failure results in a quality-relevant deviation [***]. The investigation must determine [***]. Additional, sampling, testing and checks may be performed in accordance with Matricel procedures and FDA guidance.
Failures Investigation. 4.12.1 Seller is responsible for investigating any test result or in-process test that fails to meet specification. Where appropriate, each investigation must give rise to a corrective action, which must be reviewed and approved by Seller.
4.12.2 If the recommendation is to release the batch which is the subject of such investigation as-is, the investigation must document that any failure has not jeopardized the safety, efficacy or quality of the Products. To support this assurance, additional sampling, testing and checks may be required and these must be recorded in the batch file.