BMIPP MANUFACTURING ERRORS, DEVIATIONS, AND NON-CONFORMANCES Sample Clauses

BMIPP MANUFACTURING ERRORS, DEVIATIONS, AND NON-CONFORMANCES. 7.1.1 Any error or deviation from specifications in the manufacture or testing of BMIPP must be carefully explained and documented in writing. This documentation must be included in the Batch record for affected BMIPP and retained for 7 years by Nordion. 7.1.2 Nordion shall notify Molecular Insight Pharmaceuticals within 1 days of occurrence in the event of any deviations or significant problems during manufacturing and when any test reveals contamination, lack of sterility assurance or BMIPP performance problems. Any significant deviation must be reviewed and approved by Molecular Insight Pharmaceuticals. The disposition of any BMIPP batch(s) implicated in such deviations or significant problems shall be agreed jointly between Nordion and Molecular Insight Pharmaceuticals.
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Related to BMIPP MANUFACTURING ERRORS, DEVIATIONS, AND NON-CONFORMANCES

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