- OBJECTIVE
- To describe the procedure for Quality Management Review System in order to evaluate the effectiveness of quality systems adopted to meet the cGMP and regulatory requirements. This evaluation is to ensure the continual improvement, sustainability, and effectiveness of GMP and Quality Systems and to notify the current status of compliance of the organization to the responsible senior management team of the organization.
- SCOPE
- This procedure shall be applicable for Quality Management System.
- RESPONSIBILITY
- Head of the concerned department /designee shall be responsible for the evaluation of the Quality Management Review impact in their areas.
- ACCOUNTABILITY
- Head of Quality Assurance/ designee shall be accountable for this SOP.
- DEFINITIONS
- The Quality Management Review System in the pharmaceutical industry is a structured process that evaluates and assesses the effectiveness of quality management practices within an organization. It involves reviewing quality objectives, analyzing quality metrics and data, identifying corrective and preventive actions, ensuring compliance with regulations, conducting management reviews, and promoting continuous improvement.
- PROCEDURE
- Quality systems review shall be carried out periodically for their adequacy, and effectiveness of implementation to obtain the intended outcome in the form of product quality consistently; those are manufactured and supplied or distributed by the company.
- This evaluation process is necessary to fulfill the regulatory expectations, to ensure the GMP & quality systems functioning in accordance with the regulatory requirements
- This process assures the continual improvement process of the organization. This process shall be carried out by a group of personnel, those who represent each functional department of the organization. This committee shall be termed as quality management review committee (QMRC).
- A Quality Management Review Committee (QMRC) comprises of Senior Management staff, those include Head of Quality, Head Plant Operation, Production Head, and Engineering Head. Others can be included as necessary.
- QA personnel shall be responsible for scheduling, and coordination of the meeting. He/she shall prepare the presentation (if required) & Quality Management Review Report as per the format No: SOP/QA050-F01. All the intended data required for the preparation of presentation shall be provided by respective department head /in charge in pre-defined format. Head Quality shall acts as chair person of the committee QA personnel shall be responsible for scheduling, coordination of the meeting. He/she shall prepare the presentation (if required) & Quality Management Review Report as per the format No: SOP/QA050-F01. All the intended data required for the preparation of presentation shall be provided by respective department head /in charge in pre-defined format. Head Quality shall acts as chair person of the committee
- QMR committee will meet every quarterly. All participants name shall be specified in QMR Report. If any participant participates from out-station through video-conference or tele-conference. The same shall be indicated in the report.
- QMR Committee meets to review the current status of the Quality, regulatory systems & GMP operations of the organization, the review meeting includes discussion on following topics, but not limited to:
- Deviation Reports
- Change Control System
- Incident Reports
- Out of specification Reports
- Out of trend Reports
- Market complaints
- Market recalls
- Self inspection
- Vendor audits findings and progress
- Results of regulatory inspections, customer audits & their findings.
- Other commitments made to the regulatory agencies
- Other: This section may include information like
- New Product Introduction
-
- Environmental Health & Safety (EHS)
-
- Equipment Breakdown
-
- Any abnormality recorded in other Quality System Records.
- Feedback from our regulatory department regarding new regulatory requirements & revised guidelines.
- QMRC Chairperson will propose and discuss the CAPA in the meeting. QMR committee shall reserve the right to change or modify the CAPA, if required.
- In case, if certain incidents are occurring repeatedly, the QMR committee brainstorms and decides on corrective and preventive action plans.
- In case, any capital expenditure required to complete the CAPA shall be put forward to QMR committee for approval.
- Open issues (if any) shall be discussed in QMR committee meeting and action plan shall be discussed & decided.
- Previous QMR meeting action points shall be reviewed to verify the actions taken and for their compliance status wherever applicable.
This Report shall include the following but not be limited to;
- Improvement of quality management systems & GMPs
- Allocation or reallocation of resources and/or personnel training aspectsEscalation of GMP and regulatory issuesThe Quality Management Review Report shall be circulated to the members of the
- QMR Committee to complete the action points & Senior management team for reference & necessary action.
- This report shall not be produced to any external reviewers.
- Quality Management Review report number shall be assigned as given below-
- QMR/YY/XXX
Where QMR = Quality Management Review Report
YY = Last two digits of the year in which the Quality Management meeting is performed.
XXX = Sequential number, beginning from 001.
- ABBREVIATIONS
RA : Regulatory Affair
QA : Quality Assurance
NA : Not Applicable
QMR : Quality Management Review
QMRC : Quality Management Review Committee
SOP : Standard Operating Procedure
CAPA : Corrective & Preventive Action
cGMP : Current Good Manufacturing Practices
- REFERENCES
- Guidance for Industry: Quality System Approach to Pharmaceutical cGMP Regulation, September 2006.
- ANNEXURES
Annexure -I SOP/QAXX-XXX Quality Management Review Report
- DISTRIBUTION DETAILS
- Control copy of SOP shall be distributed to
- Quality assurance,
- Quality Control,
- Human Resources,
- Microbiology,
- Production,
- Packaging,
- Warehouse,
- Engineering, and Information technology.
- Quality assurance,
- Control copy of SOP shall be distributed to
- REVISION HISTORY
| SOP Version No. | Change Control No. | Reason For Revision | Effective Date |
| 00 | CC/XX | New Document |
Quality Management Review Report
Quality Management Review Report No. : ……………………………………..
Meeting Duration: ……………. To …………..Hrs Date………………..
Participants of the Meeting
| Name | Designation | Sign/ Date |
1.0 During the meeting highlights on the following systems are to be discussed to review the current system, to eliminate the deficiencies, and upgrade the system
| Sr. No. | System Reviewed | Highlights |
| 1.0 | Deviation Handling | |
| 2.0 | Change Controls | |
| 3.0 | Incident reports & investigation results | |
| 4.0 | OOS / OOT | |
| 5.0 | CAPA’s | |
| 6.0 | Self Inspection | |
| 7.0 | Results of External Regulatory / Customer Audits & Customer Visits findings | |
| 8.0 | Vendor Audit – findings and Progress | |
| 9.0 | Results of External Regulatory / Customer Audits & Customer Visits Findings | |
| 10.0 | Outsourced Activities / Out lab Testing: | |
| 11.0 | Market Complaints | |
| 12.0 | Product Recall | |
| 13.0 | New Guideline / Change in Pharmacopeia | |
| 14.0 | Other commitments made to Regulatory agencies and their progress status | |
| 15.0 | Review of previous meeting outstanding points & their progress status | |
| 16.0 | Others (if any) |
2.0 Action points identified during meeting:
| Sr. No. | Decision / Action Taken | Probable Date/ Timeline for action | Responsibility | Remark |