Examples of Out of Specification in a sentence
Any Out of Specification (OOS) or Out of Trend (OOT) results will be investigated.
Provider will deliver a Certificate of Analysis, Documentation, completed batch documentation, any investigation reports of any Out of Specification result or Manufacturing deviation, and Certificate of Compliance along with delivery of samples of the Product for review by Client.
Any confirmed Out of Specification result which arises as a result of or during any of the stability programs will be communicated in writing within [**]to Xanodyne Corporate Quality Assurance.
A confirmed Out of Specification result is a Significant Quality Event.
Out of Specification Reports (OOS) provide details of any failure of the product to meet defined specifications and includes documentation of all assessments, investigations, decisions and subsequent corrective actions.