SOP for Management Review or Quality Review Meeting
1.0 OBJECTIVE:
To describe the procedure for periodic review of organizations integrated quality management system during Management Review Meeting or Quality Review Meeting.
2.0 SCOPE:
The scope of this Standard Operating Procedure (SOP) is to review the integrated quality management system to ensure continues suitability, adequacy and effectiveness of systems, opportunities for improvement, need for changes to the integrated quality management system during Management Review Meeting or Quality Review Meeting. This SOP shall ensure the requirements given in the Quality Policy and Quality Objectives.
3.0 RESPONSIBILITY:
3.1 Quality Assurance personnel to compile the Data related to Quality aspects for conducting the management review meeting.
3.2 Head Quality Assurance for conducting and representing the data related to Quality aspects.
3.3 Head Quality Operation / Corporate Quality for coordination the management review meeting.
4.0 PROCEDURE:
4.1 The management review shall include information Like:
4.1.1 Results of audits.
4.1.2 Change that could affect the integrated Quality.
4.1.3 Management system and recommendation for improvement.
4.1.4 Product related issue.
4.1.4.1 Change control request raised during stated period.
4.1.4.2 Deviation proposal raised during stated period.
4.1.4.3 Market complaints and response for stated period.
4.1.4.4 Reprocessing and reworking if any.
4.1.4.5 Out of specification and investigation.
4.1.4.6 Incidents occur during Review Period.
4.1.4.7 Revalidation of Products.
4.1.4.8 Stability data failure.
4.1.4.9 Raw material rejection.
4.1.4.10 Packing material rejection.
4.1.4.11 New facility required due to regulatory requirement.
4.1.4.12 Regulatory queries received for Commercial Batches.
4.1.4.13 Annual Product Quality Review.
4.1.4.14 Corrective Action Preventive Action Review.
4.1.4.15 Non Conformance Observations.
4.1.4.16 Other Related Issues that may directly or indirectly improves the Quality of the product, which may include but not limited to cGMP trainings, other external training and other appropriate matters.
4.2 The output from the management review shall include any decisions and action related to:
4.2.1 Improvement of the effectiveness of the integrated Quality Management System and process.
4.2.2 Improvement of the output related to regulatory requirements.
4.2.3 Resource needs.
4.2.4 The minutes of meeting shall be prepared with the action plan and target completion date for relevant issues as appropriate by the chain person or his/her designee.
4.3 Management Review Meeting or Quality Review Meeting Once in three months.