Unplanned Deviations. Any unplanned deviations from approved procedures, batch records, specifications or test methods will be immediately investigated, evaluated, documented and approved by Formosa’s QA unit. Formosa QA will notify NGX QA of any significant unplanned deviation occurring during a manufacturing run within [***] and of any other significant deviation within [***]. NGX QA unit will review and approve the investigation plan. NGX reserves the right to request additional or more in-depth investigation by Formosa. The documentation of the deviation, the investigation and any necessary actions required for resolution will be retained as part of the batch document for the batch(es) affected. A copy thereof will be provided [***] Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. to NGX no later than [***] after completion of the investigation by Formosa for NGX review and approval.
Appears in 2 contracts
Sources: Manufacturing Agreement, Manufacturing and Supply Agreement (NeurogesX Inc)