SOP Title: Management Review Meeting
- Objective:
To review the Quality System periodically to ensure its continuing suitability and effectiveness in satisfying the requirements of GMP and all Regulatory compliance as well as Quality Policy and objectives.
- Scope:
This procedure is applicable to all elements of Quality Management System.
- Responsibility:
All Departments Heads and Authorized persons.
- Accountability:
Director: All chairs the Management Review Meeting (MRM), review the reports presented in MRM and approve the decisions.
MR/DMR: Organize MRM, prepare and issue MRM agenda, reports, minutes, follow-up action on the decisions taken in MRM. (MR/DMR) shall chair the meeting in absence of Director
MR/DMR: Shall maintain MRM records, record of minutes.
- Procedure:
| 5.2.1 | The Management Review Meeting shall be organized once in 3 months or earlier as per requirement. | |
| 5.2.2 | Director (or a person authorized by him) shall head the meeting. Meeting to be attended by all HODs. Other staff members and outside experts (as necessary) can be invited to the management review meeting by MR/DMR. | |
| 5.2.3 | After deciding a suitable date, time and venue for the Management Review Meeting, MR/DMR shall issue a schedule along with the agenda, in advance, to the members considering the criteria in scope. | |
| 5.2.4 | Decisions for implementation of preventive and corrective actions shall be taken for points discussed, and the responsibility fixed along with target date. MR / DMR shall make minutes of the meeting and distribute to all members present. | |
| 5.2.5 | Persons responsible for implementation of preventive and corrective actions shall ensure their implementation. MR/DMR shall monitor the implementation of decisions taken in the MRM. | |
| 5.2.6 | Implementation status of various decisions taken in the previous Management Review Meeting shall be reviewed. | |
| 5.2.7 | Agenda: Following basic aspects shall be discussed and reviewed during MRM: | |
| 5.2.7.1 | · Review of quality policy and objectives.
· Assessment of Quality System effectiveness and suitability. · Review production and maintenance. · Deviations. · Change control. · Incident reports. · Rejections. · Non conforming products. · Calibration & validation status. · Customer complaints. · Resources review. · Potential area for improvements & GMP compliance. · Internal and external audit reports. · Corrective and preventive actions. · Follow up actions on the previous review. · Any other quality related subjects. · Training. |
- Abbreviation:
| Abbreviation | Expansion |
| MRM | Management Review Meeting |
| GMP | Good Manufacturing Practice |
| MR | Management Representative |
| DMR | Deputy Management Representative |
| SOP | Standard Operating Procedure |
| No. | Number |
*Note – Ready to use SOP available in “DOWNLOAD” Section.