Management Review meeting SOPs in Pharmaceuticals is prepare for future planning and GMP review. Management Review meeting is done between responsible for responsible staff.
Management Review Meeting
Management Review meeting is a formal, organized meeting that involves long-term management and takes place at regular intervals throughout the year. The purpose of a management review meeting is to evaluate and evaluate the effectiveness of your management system to help you determine your ongoing suitability and suitability.
1. PURPOSE
To coordinate and control the activities of the current Good Manufacturing Practices (cGMP) being carried out by different departments in the company and to review the performance of the cGMP.
2. SCOPE
This SOP covers all information related to cGMP Inspection, deviations, critical changes, validation activities, recall products and management review meeting.
3. RESPONSIBILITY
3.1 Quality Assurance Manager is responsible for reporting the issues; follow up of implementation of decided actions and for recording minutes of meeting.
3.2 Top Management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and those roles, responsibilities, and authorities are defined, communicated and implemented throughout the company.
3.3 Management should:
3.3.1 Participate in the design, implementation, monitoring and maintenance of an effective pharmaceutical quality system;
3.3.2 Demonstrate strong and visible support for the Pharmaceutical Quality System and ensure its implementation throughout their organization.
3.3.3 Ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management;
3.3.4 Define individual and collective roles, responsibilities, authorities and inter-relationships of all organizational units related to the pharmaceutical quality system.
3.3.5 Ensure these interactions are communicated and understood at all levels of the organization. Regional regulations require an independent quality unit / structure with the authority to fulfill the specific responsibilities of the pharmaceutical quality system;
3.3.6 Performs process and product quality management evaluation and pharmaceutical quality system;
3.3.7 Advocate continual improvement;
3.3.8 Commit appropriate resources.
3.4 Department Heads are responsible for taking actions as decided in Management Review Meeting.
4. MATERIAL & EQUIPMENT
Not Applicable.
5. PROCEDURE
5.1 Meetings are chaired by the Chief Executive Officer or Managing Director and must be held once in every year. However, the frequency of the meeting can be increased for the follow-up of corrective action.
5.2 Quality Assurance Manager prepares document “Notice/Agenda for Management Review Meeting” and circulates it to regular members and designated person mentioned on “Notice/Agenda for Management Review Meeting”.
5.3 Agenda / Inputs of review meeting
5.3.1 Previous Management Review Actions
5.3.2 Inspection Result (Internal & External assessments such as regulatory inspections and findings and customer audits).
5.3.3 Deviations
5.3.4 Validation Activities
5.3.5 Product changes
5.3.6 Recall Products
5.3.7 Any other problem related to cGMP
5.4 Review Output
5.4.1 Resources requirement (Provision, training and/or realignment of resources)
5.4.2 Improvement of the cGMP and its processes.
5.5 Quality Assurance Manager reports to the Top Management and explains issues as needed.
5.6 Quality Assurance Manager lists actions and minutes of Management review meeting in the document “Minutes and Actions of the Management Review Meeting”.
5.7 Quality Assurance Manager ensures implementation of the Management Review Actions through Department Heads and intimates the status to the Chief Executive Officer/ Executive Director, in the next Management Review Meeting.
5.8 Quality Assurance Manager retains the record of Management review meeting agenda, its minutes & actions for the last two years.
6. REPORTING
6.1 Notice / Agenda for Management Review Meeting
6.2 Minutes and actions of the Management Review Meeting
7 REFERENCE DOCUMENTS
7.1 SOP for Product Recall
7.2 SOP for Validation Master Plan
7.3 SOP for Product Change Control
7.4 SOP for Deviation Management
7.5 SOP for cGMP Self Inspections