1.0 Objective
To lay down a procedure for Quality Management Review.
2.0 Scope
This procedure is applicable at pharmaceutical formulation plant. The objective of Quality Management Review is to conduct reviews of the whole quality system according to a planned schedule. This includes the review of both operational and quality system review.
3.0 Responsibility
3.1 Head Quality Assurance: Shall be responsible for compliance of this SOP
3.2 Head’s of Production, QC, Stores, Engineering, Administration, HR, Materials Management, Regulatory Affairs, etc. shall be responsible for implementation and compliance of the SOP.
4.0 Abbreviations & Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
CFT : Cross-Functional Team
CAPA : Corrective and Preventive Action
5.0 Procedure
5.1 Quality Management Review shall be done by Quality council, headed by Head Quality Assurance, comprising of head’s of Production, QC, Stores, Engineering, Materials Management, Regulatory Affairs department, Head operations, and Plant head.
5.2 Quality council shall provide the framework for implementing the quality procedures, establishing the suitability of the quality system, its adequacy and effectiveness, continuous improvement and risk management.
5.3 Quality council shall:
5.3.1 Ensure that controls are implemented and completed satisfactorily during manufacturing operations
5.3.2 Ensure that developed procedures and specifications are appropriate and followed, including those used under the contract manufacturer
5.3.3 Approve or reject in-process materials and drug products — although such activities do not substitute for, or preclude, the daily responsibility of manufacturing personnel to build quality into the product.
5.3.4 Review production records and investigating any unexplained discrepancies and address nonconformities.
5.4 A calendar for Operation and Quality Review meetings for next 12 months (Annexure I) shall be prepared by Quality Assurance and put into circulation to all concerned departments by Head Quality Assurance. If there is any exigency, then the new date shall be finalized with due consent of all the concerned departments.
5.5 Operational Review
5.5.1 Quality council shall plan strategy for accomplishment of targets e.g. raw material availability, equipment availability, man power availability etc., evaluate the preset target of last month, preventive maintenance status of equipments. Quality council shall set new Production, QC, Stores, QA, Administration, or Engineering target for next month as per market requirement or regulatory requirement.
5.5.2 Quality council shall plan on strategies and system to be followed for audits / visits to take place in next month. Quality council shall discuss implementation status of CAPA for previous month’s audits, if any. The council shall also discuss all the relevant quality related issues to location.
5.5.3 Operational review shall be performed to ensure targets set are accomplished, if not than what are the constraints to achieve those targets.
5.5.4 Operational review meeting shall be held on 7th of every month. If it is a holiday than, meeting shall be held on succeeding day.
5.5.5 Meeting shall be concluded with solutions for all issues raised in meeting.
5.5.6 Minutes of meeting shall be prepared and documented.
5.5.7 A cross functional team (CFT) shall be designated by quality council comprising of members of QC, QA, warehouse, Production and administration department.
5.5.8 Time bound target shall be assigned to CFT.
5.5.9 CFT shall workout the practicality of the target and start working towards accomplishment of the target.
5.5.10 There shall be weekly meeting of CFT regarding discussion on constraints if any towards accomplishment of target, and finalizing resolution for constraints. (e.g. if CFT is given a target of reduction in quantity of non recoverable recovery for a particular product. Time period assigned is 8 weeks. And CFT is having constraints over wastage due to mishandling during manufacturing. Then, CFT shall come out with a solution during the meeting to update operators with techniques which reduce quantity of non recoverable recovery).
5.5.11 CFT shall submit its report during operational review. In meeting constraints and achievements of the target shall be discussed.
5.5.12 If, CFT could not achieve target within given time period, then time period shall be extended only on approval from Quality council.
5.5.13 After accomplishment of assigned target CFT shall be assigned new target.
5.6 Quality System Review
5.6.1 Quality system review shall be done by team headed by Head Quality Assurance, and his team of managers in the department on 15th of every month. If it is a holiday than, meeting shall be held on succeeding day. Other members from Quality Assurance or other departments may also be invited to attend the meeting as per the requirement.
5.6.2 The quality review shall include:
5.6.2.1 Analyze Data for Trends: This shall be done by monitoring data and information, identifying and resolving problems, and anticipating and preventing problems.
5.6.2.2 Conduct Internal Audit: Internal audits shall be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications.
5.6.2.3 Risk Management: Quality risk management shall be done for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle.
5.6.2.4 Corrective Action: Corrective action shall be developed and documented, the root cause of the problem shall be investigated, possible actions determined, a selected action shall be taken within a defined timeframe, and the effectiveness of the action taken shall be evaluated.
5.6.2.5 Preventive Action: A preventive action procedure shall ensure that potential problems and root causes are identified, possible consequences assessed, and actions considered. The selected preventative action should be evaluated and recorded, and the system shall be monitored for the effectiveness of the action. Problems can be anticipated and their occurrence prevented using information from reviews of data and risk analyses associated with operational and quality system processes, and by keeping abreast of changes in scientific and regulatory requirements.
5.6.2.6 Promote Improvement. Team shall evaluate quality management system and set new targets for improvement in quality management system.
5.6.3 Team shall evaluate all the documents and discuss all issues of concern in plant.
5.6.4 Team shall discuss on BMR related issues, Change controls filled in last month, Deviations, Out of specifications, non conformance records, CAPA market complaints, product recalls, IPQA related issues, list of SOPs to be taken under review and their review status, pending status of documents to be reviewed and distributed, Issues related to art work approval or shade card distribution, License related issues, Issues related to major rejections in raw material, vendor approvals etc.
5.6.5 Team shall also discuss on CAPA implementation status of previous issues, discussed in last month’s meeting.
5.6.6 Meeting shall be concluded with possible solutions for all issues raised in meeting.
5.6.7 Minutes of the meeting arising from Operational and Quality management review shall be compiled and noted in Operation and Quality Management review Record (Annexure II).The approved minutes of
5.6.8 The approved minutes of meeting shall be forwarded to all the area / functional In-charges as per the relevance of the points.
5.6.9 A consolidated monthly report of all quality related issues shall be sent to Joint Managing Director for his information preferably during first week of every month. A copy shall also be sent to the Director, Operation and Projects. Further, as per requirement a meeting shall be requested by Head QA from Joint Managing Director for arriving at necessary CAPA.
`6.0 Forms and Records
Calendar for Operation and Quality system review : Annexure 1
Operation and Quality Management review Record : Annexure 2
7.0 Distribution
7.1 Master Copy : Documentation Cell (Quality Assurance)
7.2 Controlled Copies : Quality Assurance, Quality Control, Production, Stores, Finished goods warehouse, Engineering, Regulatory Affairs, Research and Development, Materials Management, Human resource, Administration & Housekeeping
8.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Calendar for Operation Review and Quality Review Meetings
Financial Year:…………..……
| Month | Operation Review* | Quality System Review** | ||||
| Expected Date | Meeting Held On
Date (Time)*** |
Remarks | Expected Date | Meeting Held On
Date (Time)*** |
Remarks | |
| April | 7th | 15th | ||||
| May | 7th | 15th | ||||
| June | 7th | 15th | ||||
| July | 7th | 15th | ||||
| August | 7th | 15th | ||||
| September | 7th | 15th | ||||
| October | 7th | 15th | ||||
| November | 7th | 15th | ||||
| December | 7th | 15th | ||||
| January | 7th | 15th | ||||
| February | 7th | 15th | ||||
| March | 7th | 15th | ||||
* To be attended By Quality Council
** To be attended By Head Quality Assurance and his team of Managers and those who have been invited.
***Actual date on which the meeting is Held
Annexure-II
Operation Review/Quality system Review Record
Month: Year:
| S.No | Activity/Action Plan | Responsibility Centers | Initiation Date | Expected date | Status | Priority |
