MANAGEMENT REVIEW OF QUALITY METRICS
Management review of quality Metrics procedure provides Monthly/ Quarterly Management Review and
assessment of the performance of Quality and GMP systems. This document describes the activities of the Quality review meeting.
SCOPE OF MANAGEMENT REVIEW OF QUALITY METRICS:
This procedure applies to all facilities related to Production, Packaging, Testing, Holding, Distribution, and any other sources that provide information for a potential serious discrepancy.
RESPONSIBILITY:
- Monthly Site Quality Review Report:
Site Quality Assurance:
- The Site Quality Assurance (QA) personnel shall be responsible for Preparing monthly Site Quality Review Reports/Presentations.
Site Quality Head/ Designee:
- The Site Quality Head/ Designee shall review the Monthly Site Quality Review Report/ Presentation.
Site Quality Review Meeting Coordinator:
- Site QA Head/Designee will act as the Site Quality Review Meeting Coordinator.
- The Site QA Head /Designee shall review the Monthly Site Quality Review Report/ Presentation.
- Scheduling Site Quality Review meetings every month.
- Preparing and distributing the meeting agenda before the date of the meeting.
- Coordinating and maintaining the Metrics for review by the Site Quality Review members and ensuring specified Metrics are reported by the Site. by the schedule.
- Preparing and distributing the minutes of the Site Quality review meeting.
- Following up on actions and decisions from the Site Quality review meeting.
- Monitoring attendance of the Site Quality Review meeting.
Site Quality Review Members shall;
- Participate in the Site Quality Review meeting.
- Guide/ Provide directions on serious discrepancies and monitor the same.
- Participate in the identification of potential compliance issues.
- Review the Minutes of the Site Quality Review Meeting.
- Review Monthly Metrics Report
- Ensure the availability of necessary resources.
The members of the Site Quality Review meeting shall be as follows but not limited to:
- Plant Head
- Head – Quality
- Head – Quality Assurance
- Head – Quality Control
- Head – Production
- Head – Regulatory Affairs
- Head – Warehouse
- Head – Engineering
- Head- IT
Quarterly Quality Review Presentation:
Quality and Compliance Head/ Designee:
Quality and Compliance (CQC) department shall be responsible for preparing a consolidated Quarterly Quality Review Presentation.
Quality Review Meeting Coordinator:
Quality Review Meeting Coordinator (CQC Head/ Designee) shall be responsible for;
- Scheduling Quality Review meetings every quarter.
- Preparing and distributing the meeting agenda before the date of the meeting.
- Coordinating and maintaining the metrics for review by the Quality Review Meeting members and ensuring specified metrics are reported by each site by the schedule.
- Preparing and distributing the minutes of the Quality Review meeting.
- Following up on actions and decisions from the Quality Review Meeting.
- Monitoring attendance of the Quality Review meeting.
Quality Review Meeting Members shall;
Participate in the Global Quality Review meeting.
Guide/ Provide directions on serious discrepancies and monitor the same.
Participate in the identification of potential compliance issues.
Review the Minutes of the Quality Review Meeting.
Review Quarterly Quality- Review Presentation.
Ensure the availability of necessary resources.
The members of the Quality Review Meeting shall be as follows but not limited to:
- Director – Operation
- Vice President – Operation
- Head – Research & Development
- Head – Corporate Quality & Compliance
- Head – Regulatory Affairs
- Head – Business Development
- Head- IT
- Head-Corporate Human Resource
- Sites – Quality Head
- Sites – Plant Head
Employees: Any employee who discovers or is made aware of a potentially serious discrepancy shall report the event to the site management.
DEFINITIONS:
Metrics:
Specific parameters that shall be continuously monitored and are considered to be key performance indicators of quality as well as the effectiveness of the six systems: Facilities & Equipment, Materials,
Laboratory Control, Production, Packaging & Labelling and Quality Systems.
Quality Review Meeting Coordinator:
A functional responsibility that consists of scheduling the review meeting, coordinating the metrics, organizing the metrics into the appropriate format for the Monthly/ Quarterly forum, and taking notes at
the meeting for distribution of the Minutes of Quality Review meetings.
Minutes of Quality Review meeting:
The brief representation of the proceedings of the meeting, including any presentations, of the issues presented/ discussed at the meeting, any follow-up items, and any decisions reached.
Serious Discrepancy:
A significant departure from the standard operating procedure, event, complaint, significant departure out-of-specification event, or other significant discrepancy event has the potential to impact product safety, quality, identity, purity, or efficacy. A serious discrepancy would typically be an event, that would have an impact on distributed products or is of a nature considered to be indicative of a system failure.
Trends:
A statistical term referring to the direction or rate of change of a variable(s).
PROCEDURE:
SITE QUALITY REVIEW MEETING:
Site Quality Review Meetings shall be done at respective Sites every month.
Following shall be the members of the Site Quality Review Meeting but not
limited to:
Plant Head
Head – Quality
Head – Quality Assurance
Head – Quality Control·
Head – Production
Head – Regulatory Affairs
Head – Warehouse
Head – Engineering
Head- IT
Monthly Site Quality Review Reports and Presentations shall be prepared and reviewed by Site Quality Assurance.
CORPORATE QUALITY REVIEW MEETING:
The Corporate Quality Review Meeting shall be held at Head Office every quarter.
The members of the corporate quality Review Meeting shall be as follows but not limited to:
- Director
- Head – Corporate Quality & Compliance
- Head – Operation
- Head – Research & Development
- Head – Regulatory Affairs
- Head – Business Development
- Head-Corporate Human Resource
- Sites – Quality Head
- Head- IT
- Sites – Plant Head
Quarterly Corporate Quality Review Presentation shall be prepared and reviewed by the Corporate Quality & Compliance department.
MONTHLY SITE QUALITY REVIEW REPORT :
Each Site QA personnel shall prepare and send the Monthly Site Quality Review Report and Presentation to the Site Head, Site QA Head, and Site Quality Head. Site QA personnel may refer to the template for the Monthly Site Quality Review Report, Monthly Site Quality Review Metrics Report, and Monthly Site Quality Review Presentation during preparation of the monthly report.
The Monthly Site Quality Review Report shall include the summary of the following for the reporting Month and any pending status of the previous Month(s) as applicable:
Production Volume and testing summary
Laboratory Testing:
This shall include the data for samples of Raw materials, Packaging materials, in-process, Intermediates, Semi-finished, Finished products, Stability study, and Microbiology.
- Market Complaint
- Product Recall
- Returned Goods
- Major Deviations
- OOS – Chemical (Stability/ Exhibit Commercial Products)
- OOS – Micro (Stability/ Exhibit/ Commercial Products)
- Out of Calibration (OOC)
- Regulatory, Customer, Corporate Quality & Compliance & Self /Internal Inspections.
- Batch Reprocess and Batch Reworked
- Out of Trend (OOT)
- Laboratory Errors
- Change Controls
- Media Fill
- Training
The Monthly Site Quality Metrics Review Report shall include the summary of the following for the reporting Month and any pending status of the previous Month(s) as applicable:
- Lot Acceptance rate
- Product Quality Complaint rate
- Invalidated OOS rate (Stability and Commercial Finished Product)
- Annual Product Quality Review time rate
- Timeliness Metrics for closures (Market Complaint, OOS, Deviation and Change Controls)
- Status of CAPA (Market Complaint, OOS, and Deviation)
Site QA Head /Designee shall organize a Meeting on a Monthly Site Quality Report/ Presentation with the Site Quality Review Meeting members.
The Site team shall review, discuss, and assess each Metrics and conclude if any additional action is necessary to correct/ control the events and shall assign tasks and follow-up action with the target completion date and the same shall be formally documented in the minutes.
While reviewing the Monthly Site Quality Review Report/ Presentation, the previous Month’s pending actions shall be discussed and the status of implementation of the proposed action plan shall be reviewed and updated in Minutes of Meetings.
The Site QA Head/ Designee shall prepare the Minutes of Meetings and distribute them to all the attendees. Attendance shall be recorded and the same shall be verified by the meeting coordinator.
Quarterly Corporate Quality Presentation Review:
Quarterly data evaluation shall be done by the site and CQC shall prepare the Quarterly Corporate Quality Review Presentation comprising the Quality Presentation of previous Months’ quality data, received from sites. The CQC shall collate the data from all Sites and prepare a consolidated summary report.
In case the quality meeting differs from the quarterly frequency, then quality data to be presented in upcoming meetings where the previous month’s data shall be included with a recent quarter for review. e.g. If the first quarter (Jan to March) meeting is conducted in May instead of April month then the first quarter & April month data shall be reviewed and presented in the meeting.
For next quarter’s review period, Quarterly frequency for data compilation and review shall be maintained from the month of the previous quarterly quality meeting. e.g. If the first quarter (Jan to March) meeting is conducted in May month instead of April month then the next quarterly quality meeting will be done in August Month (May to July).
The Corporate Quality Review Meeting coordinator shall send the Quarterly Corporate Quality Review presentation to the CQC Head/Designee for review before the Corporate Quality Review meeting.
A Corporate Quality Review meeting will be held after the completion of every Quarter (January to March, April to June, July to September, and October to December) to review the Quality Metrics of each site with
the members of the Corporate Quality Review meeting.
The agenda for the meeting shall be issued by the Head/ Designee Corporate Quality & Compliance and include a review of the following but not limited to:
• Review of performance metrics
• Requested Presentations on any Metrics and/ or trends that need further discussion, if any
• Any other topics as per agenda or as per Corporate Quality Council instructions.
The Corporate Quality Review meeting members shall assess each of the Metrics and determine if any additional action is necessary to correct any trends that may be evident through the evaluation.
The Corporate Quality & Compliance Head/Designee shall be present at the Corporate Quality Review presentation in the meeting, where the CQC Head/Designee may discuss the following points but not limited to:
- Quality Strategy
- Regulatory Inspection status
- Site Quality Performance Report
- Quality Metrics
- Improvement Plans and Quality Initiatives
- Way Forward
Note: Corporate PPT contents are dynamic where appropriate updation can be done as per requirement.
Each Site Quality Head/Designee individually shall be responsible for presenting respective Site Quality review presentation in the Corporate Quality Review Meeting
The Corporate Quality Review meeting members shall assign tasks and follow-up action, as deemed appropriate, with specific follow-up dates. Follow-up actions, including the target completion date, shall be formally documented in the minutes.
The Corporate Quality and Compliance Head/ Designee shall prepare the Minutes of Meetings and distribute them to all the Attendees of Global”Quality Review meeting members.
The Corporate Quality and Compliance Head/ Designee shall ensure all trends are addressed and any pending issues are monitored until resolution is achieved. Closure of pending issues shall be documented in the minutes of the Quality Council Meeting.
Attendance shall be recorded and the same shall be verified by the meeting coordinator.
