Follow
Objective: To review the Quality Management System implementation status and to plan for resolving any outstanding issue and for closing the gaps.
Scope: This SOP is applicable for holding Annual Quality Management Review meeting system in (Company Name).
Responsibility:
O Team members of concerned departments shall attend the meeting to present their current status, proposals, views, observations and recommendations for improvement of current quality management system.
O Secretary will coordinate the meeting.
O Chairman will chair the meeting.
O QA shall be responsible for effective implementation of the procedure.
Accountability: Head of Quality
Precautions: Not Applicable
Procedure:
O A meeting for review of quality management system will be held preferably at the end of each year.
O Representative from QA, QC, Production, Engineering, Warehouse, Training, R&D and HR will attend in the meeting.
O Secretary of meeting will ask for meeting agenda from the team members and make final agenda.
O To review current status of Quality Management System the participants should –
O Review minutes of previous meeting, status and issues of changes, non-conformance, deviations and CAPAs that are under implementation. For any outstanding issues suggested actions to be recorded.
O Review Quality audit findings and review status by both external agencies (including regulatory authority) and self-inspection team and corrective actions arising out of those.
O Review of previously scheduled training effectiveness.
O Review and agree validation action plan.
O Review vendor audit status.
O Review the status and trends obtained from record of critical parameter of environment, utility (water, compressed air and nitrogen gas) temperature and humidity, microbial count, particle count (sterile facility) etc.
O Review the status of previous market complaints and corrective action taken to minimize if any potential risk (if any).
O Review repeated incidence report(s).
O Review repeated raw & packaging material discrepancy report(s).
O Review of OOS/Atypical reports, stability study issues and material & product rejection.
O Review of maintenance & calibration status.
O After the meeting, Secretary of meeting will prepare the minutes of meeting and circulate to all participants copying to Managing Director & COO.
O Secretary will preserve all records related to the meeting.
O Meeting frequency: Annually.
