Quality Review Meeting, Purpose :
Quality Review Meeting, To define the Quality Review Meeting requirements to ensure that the review and escalation of quality and. Assurance risks, improvement opportunities and strategy settings are handled effectively.
Quality Review Meeting, Scope :
This SOP is applicable for holding Quality review meeting of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]CAPA : Corrective Action and Preventive Action
[][]IPC : In-Process Check
[][]QMS : Quality Management System
[][]OOS : Out of Specification
[][]PPR : Periodic Product Review
Responsibilities:
[][]The roles and responsibility is as follows:
Manager, Quality Assurance
[][]Facilitate the Quality Review Meeting.
[][]Prepare the yearly calendar for the meeting.
[][]Recommend the participant list.
[][]Prepare the meeting agenda.
[][]Communicate with the participants for the meeting.
[][]Prepare and issue the minutes.
Manager, Quality Control
[][]Update Environmental monitoring/ Laboratory system/ KPI/ Rejection.
Head of Engineering
[][]Update maintenance status of plant/machinery.
Head of Plant Operation
[][]Chair the Quality Review Meeting.
Head of Quality Assurance
[][]Approve the yearly calendar for the meeting.
[][]Approve the meeting agenda.
[][]Approve the participant list.
Procedure:
Overview of Quality Review Meeting:
[][]Quality Review Meeting is an essential part of the governance and improvement framework for Quality and Regulatory Assurance within XX Pharmaceuticals Limited.
Operation of the Site Quality Review Meeting:
Attendance
[][]It is essential to have adequate senior representation of quality, operational, and supporting roles at the QRM. The ownership of this Quality Review Meeting lies with Head of Quality Assurance. The meeting will be chaired by Head of Plant Operation or his designee.
[][]The Team members of Quality Review Meeting will be all technical person of the Plant. It is essential that the members shall be present in all the meetings. To conduct a meeting at least 70% participation of the members is mandatory. However, either one of i e Head of Plant or Head of Quality Assurance must be present in the meeting.
Frequency
[][]The QRM will be held on monthly basis. A yearly calendar will be followed, which will be issued at the beginning of the year. The responsibility lies with Head of Quality Assurance.
Meeting Process and Communication
[][]It is the responsibility of Head of Quality Assurance to notify the members of QRM a week before the meeting with agenda (Annexure I).
[][]The members will give their feedback on their part of actions at least three days before the
[][]meeting to the Head of Quality Assurance. This will facilitate the process of updating the previous meeting.
[][]The minutes will contain the following attributes:
For actions and decisions
=>Owner (a single name in preference to group actions)
=>Content
=>Context for full understanding/reason including related agenda item.
=>Current status of action
=>Target completion date
Record Maintenance
[][]Manager, Quality Assurance will maintain all records of the Quality Review Meeting as per SOP for Document Archiving, Retention, and Retrieval & Destruction. Following records will be maintained:
=>Minutes
=>Actions taken
=>Decisions taken
=>Communications
Brief Description of Agenda items
Review of CAPA status
=>Review actions for most significant CAPAs
=>CAPA update on Level of internal audits
[][]Changes to regulatory requirements
=>Quality Review Meeting will Review of any new regulatory requirement that is to be addressed.
[][]Quality Management System
=>Confirm that the review of current practices/standards gaps versus the QMS is rigorous.
=>Review actual QMS performance versus target.
=>Review significant changes within the QMS.
Risk Management – Governance and Improvement
[][]Risk Register: The Quality Risk Register must be reviewed to ensure
=>Risks are being identified.
=>Risks are being assessed.
=>Action plans are being progressed.
[][]Periodic Review of QRM Plan
=>Schedule adherence of QRM Plan
=>Endorse new Quality Plan and any change in Quality plan
[][]Quality KPI Review
=>Batches Not Right First Time (Process & Testing error)
=>Batches Not Right First Time (Documentation error)
[][]Change Controls
=>Review the overall status of Change Control Tracker and ensure there is no overdue.
=>Endorse the final closing of Change Control
=>Review all critical and major change controls.
=>Check that the closure is timely and the actions taken are effective
[][]Deviations, Out of Specifications, Rejects and Reworks
=>Quality Review Meeting will
=>Review deviations, OOS, rejects and reworks
=>Assure itself that reporting is full and complete and that closure is timely (Investigation will not open more than 30 days).
=>Review overall trends and set strategic improvement actions.
[][]Complaints – Vendor and Customer
=>QRM will Ensure that all vendor and customer complaints are reviewed.
=>Ensure that any ‘unofficial’ complaints or comments are reviewed
=>Review the root cause and proposed CAPA
=>Review overall trends and set strategic improvement actions.
=>Review Recalls and Product Incident Review. .
=>Understand and endorse resultant CAPAs.
[][]Periodic Product Review
=>Quality Review Meeting will review.
=>Schedule adherence for the year, and monitor timely completion.
=>Key findings (executive summary) of PPR.
=>Improvement recommendations (CAPA) in PPRs are actioned and tracked.
=>Adverse quality trends are reviewed and actioned.
=>Positive quality trends are reviewed to ensure sustainability (or transfer of a good practice).
=>Correlate change controls with product quality trends.
[][]Validation
=>Schedule adherence of VMP
=>Issue triggered from validation
[][]Stability Studies
=>Review stability test status.
=>Review any adverse stability data and assess impact on product quality and shelf life
=>Take corrective action to mitigate the risk.
[][]Environmental/Utility Issues
=>Review any adverse trend of environmental monitoring results and results of water testing and to assess impact on product quality.
=>Take corrective action to mitigate the risk.
[][]Training
=>Progress against plan (Schedule adherence)
=>Man-hours utilized Retention & Archiving of Documents
[][]Retention & Archiving of Documents
=>Progress against plan
[][]Preventive Maintenance
=>Schedule adherence
[][]IPC Trending
=>Review the monthly IPC observations for any GMP non Compliance
=>Review the IPC observation trend to minimize the IPC failure/ error.
[][]Review of last minutes
=>Comments on previous minutes from the participants.
=>Track progress of actions in the previous minutes of the meeting.
[][]Any other matters to discuss
=>Any other matters not discussed earlier but have an impact on product quality.
[][]After Action Review
=>At the end of the meeting members will review the meeting process, confirm whether it has met the purpose and identify the needs for its improvement for the next meeting.
Annexure:
Annexure-I: Agenda of Quality Review Meeting