Common use of Deviation Report Clause in Contracts

Deviation Report. In the event that during the manufacture or ---------------- other handling of a Product by Supplier (i) the process or analytical limits exceed established report ranges, (ii) other events occur which could affect quality or otherwise are unusual or not expected, (iii) there is any reason to doubt full compliance of such Product with the Specifications, or (iv) an unplanned processing event leads to a deviation outside registered or defined processing parameters, then Supplier shall investigate and prepare a written report detailing such factors (a "Deviation Report"). Attached as an exhibit to such Deviation Report shall be copies of all relevant batch records. Any such investigations and reports regarding Primary Products to be used in the manufacture of Secondary/Steriles Products shall be reviewed and approved by GWI prior to incorporation of such Products into any Secondary/Steriles Products.