1.0 PURPOSE:
2.0 SCOPE:
This procedure is applicable to management review meeting (MRM). The meeting is conducted for assessing the quality management system and escalating quality issue to the appropriate level of management.
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 Head QA of the organization shall be the chairperson of the meeting.
4.2 Head-quality is responsible to conduct the review meetings.
4.3 Functional heads like, Business Development, Manufacturing, Purchase, Engineering, Quality Control and Quality Assurance shall give the appropriate inputs for improvement in QMS.
4.4 Members of the Site Quality Management Review (MRM) Team (mentioned as below) shall be responsible for participation / discussions / interactions and implementation of the recommendations as finalized in the Site Quality Review Team Meet.
4.5 Management Review Meeting Team Members:
4.5.1 Head QA (chairperson)
4.5.2 Head Production / Designee
4.5.3 Head Warehouse / Designee
4.5.4 Head – Plant / Manufacturing
4.5.5 Head QC / Designee
4.5.6 Head Engineering / Designee
4.5.7 Representative of any other department as required (FDD/R&D/ HR/Purchase).
5.0 PROCEDURE:
5.1 The management review meeting (MRM) shall be conducted once in three months (Quarterly) for ensuring timely, effective communication and to escalate quality issue up to appropriate levels of management.
5.2 Entire three months starting from first to last day of the quarter shall be consider as a review period.
5.3 QA Head/Designee shall schedule management review meeting (MRM) and circulate agenda for the same to all concerned.
5.4 Head QA can invite other member as per requirement for the meeting from the same or other sites.
5.5 Head QA conducts the meeting and reviews the performance of Quality Management System through management review meeting.
5.6 All Department Heads /Site Head /QA Head explain the relevant details during management review meeting.
5.7 The agenda of Management Review Meeting (MRM) includes the following points but not limited to;
5.7.1 Review of previous minutes of meeting.
5.7.2 Quality System
5.7.2.1 Annual Product Quality Review, Regulatory submission and compliance.
5.7.2.2 Deviation, Change control and Incidents.
5.7.2.3 Laboratory investigation reports (OOS)
5.7.2.4 Stability studies
5.7.2.5 Market complaint, adverse drug reaction, adverse drug event, Field Alerts, Recalls and Returned goods.
5.7.2.6 Control of conforming, non-conforming materials and products.
5.7.2.7 Investigation.
5.7.2.8 Corrective and Preventive action (CAPA).
5.7.2.9 Internal Quality Audits and compliance.
5.7.2.10 Schedule customer / Regulatory audits and compliance status of previous audits.
5.7.2.11 Review of customer feedback.
5.7.2.12 Review of QMS process performance.
5.7.2.13 Review of changes in QMS.
5.7.2.14 Training review.
5.7.2.15 Review of resources.
5.7.2.16 Review of revised or new regulatory requirements.
5.7.2.17 Review of any other quality related issues.
5.7.3 Improvements:
5.7.3.1 In product due to regulatory /pharmacopeia / customer requirement.
5.7.3.2 In Facility, Utility.
5.7.4 New Product schedule, Validation, Technology Transfer and Pre-exhibit / exhibit batch (es) schedule in next meeting shall be reviewed.
5.7.5 Requirement of resources like capital purchases, manpower or any other specific requirement for new products.
5.7.6 Any other matter directly or indirectly related to GMP may be discussed.
5.8 Review Output:
5.8.1 Head -QA ensures that the discussions are relevant to the agenda point.
5.8.2 QA Head reports the outcome of the management review meeting (MRM) as Minutes of Meetings and forwards these to Site Head and concerned department heads as per the Annexure-I.
5.8.3 Site Head or QA Head shall take follow up regularly on the progress of the action points, as applicable.
5.8.4 Site Head or QA Head shall ensure implementation / monitoring of decisions of the Management Review Meeting (MRM).
6.0 ABBREVIATIONS:
6.1 MRM :Management Review Meeting
6.2 SOP :Standard Operating Procedure
6.3 GMP :Good Manufacturing Practices.
6.4 OOS :Out of Specification
6.5 CAPA :Corrective and Preventive Action
7.0 REFERENCES:
7.1 21 Code of Federal Regulation, Part 210 and Part 211
7.2 EU Guidelines for Good Manufacturing Practices for Medicinal Products for Human and Veterinary use, Chapter 1, Pharmaceutical Quality System
7.3 Rules and Guidance for Pharmaceutical Manufacturers and Distributers, MHRA
7.4 ICH Q7A: Good Manufacturing Practice for Active Pharmaceutical Ingredients.
8.0 LIST OF ANNEXURES:
Annexure-I: Quality Management Review Meeting.
