Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 14: Corrective and preventive actionPrincipleThe cause(s) of actual and potential nonconformance in product, process or the quality systemitself should be identified and eliminated. Action should be appropriate to the severity of thenonconformance. Changes resulting from corrective and/or preventive action should bedocumented and adequately controlled.14.1 Corrective action14.1.1 Corrective action is intended to both rectify an existing nonconformance and avoid arecurrence. It is, therefore, necessary to identify the underlying cause of the problem.14.1.2 Corrective action may arise from customer complaints, audit findings, managementreviews and other situations where nonconformance is likely to be identified.14.1.3 All customer complaints should be recorded, promptly investigated and reported inaccordance with a written, approved procedure.14.1.4 A carefully planned and timely investigation should take place to determine thereason(s) for the nonconformance and agree appropriate action.14.1.5 Details of the nonconformance, the associated investigation and agreed actionsshould be recorded.14.1.6 Progress with agreed actions resulting from the nonconformance investigationshould be closely monitored until all are satisfactorily completed.14.1.7 A written, approved procedure should clarify in what circumstances recall of an APIshould be considered. This document should also indicate responsibilities and actionsin the event of a recall.14.1.8 In the event of a serious and potentially life-threatening situation, (local and national)authorities should be informed and their advice sought.14.2 Preventive action14.2.1 Preventive action is intended to avoid the initial occurrence of a nonconformance.42