Quality systems review by management.

1.0 OBJECTIVE

To lay down a procedure for quality systems review by management. 

2.0 SCOPE

This procedure is applicable quality systems review by management at XXX, Company. 

3.0 RESPONSIBILITY

3.1 MD-Managing director

3.2 Heads- all departments  

4.0 PROCEDURE  

4.1 Quality Systems review by Management shall be done by Quality council, headed by Managing director comprising of head’s of Quality assurance, Production, QC, Stores, utilities and administration. 

4.2 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.

4.3 Quality council shall: 

4.3.1 Ensure that controls are implemented and completed satisfactorily during manufacturing operations 

4.3.2 Ensure that developed procedures and specifications are appropriate and followed, including those used under the contract manufacturer 

4.3.3 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. 

4.3.4 Review production records and investigating any unexplained discrepancies and address nonconformities.

4.4 Quality System Review 

4.4.1 Quality system review shall be done by team headed by Head Quality Assurance, and his team of managers in the department on every three months. Other members from Quality Assurance or other departments may also be invited to attend the meeting as per the requirement. 

4.4.2 The quality review shall include: 

4.4.2.1 Analyze Data for Trends: This shall be done by monitoring data and information, identifying and resolving problems, and anticipating and preventing problems.

4.4.2.2 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. 

4.4.2.3 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. 

4.4.2.4 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. 

4.4.2.5 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. 

4.4.2.6 Promote Improvement. Team shall evaluate quality management system and set new targets for improvement in quality management system 

4.4.2.7 Team shall evaluate all the documents and discuss all issues of concern in plant. 

4.4.2.8 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. 

4.4.2.9 Team shall also discuss on CAPA implementation status of previous issues, discussed in last month’s meeting. 

4.4.2.10 Meeting shall be concluded with possible solutions for all issues raised in meeting. 

4.4.2.11 Minutes of the meeting arising from  Quality management review shall be compiled and noted in Quality Management review Record (Annexure I).

4.4.2.12 The approved minutes of meeting shall be forwarded to all the area / functional heads as per the relevance of the points. 

4.4.2.13  A consolidated monthly report of all quality related issues shall be sent to Managing Director for his information preferably during first week of every month.

5.0 ABBREVIATIONS

5.1 SOP-Standard Operating procedure 

6.0  ANNEXURE 

6.1  Annexure-1:Quality system review record