Contents
Article 9Corrective and preventive action and change management#
1.Marketing authorisation holders shall have a process in place for managing corrective and preventive actions, to mitigate any deviations detected in audits, daily operational work and findings from inspections. Associated corrective and preventative actions shall be documented for the last 5 years.
2.Corrective and preventive action plans requested by the competent authority shall document in writing an effective process, systematically addressing and minimising identified risk or defects. It shall include root cause analysis, address clear possible corrective and preventive measures, address timelines for action, and communication to relevant stakeholders.
3.Marketing authorisation holders shall monitor and assess the effectiveness of corrective and preventive actions. Any changes associated with those actions shall be evaluated.
4.Change management shall provide for a controlled process of change, including monitoring and documenting the effectiveness of the corrective or preventive actions and communication to relevant stakeholders.
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