Quality management System_Quality Assurance

1. Quality management system QUALITY ASSURANCE

2. Quality Management system elements: • Change management • Deviations • CAPA • Self Inspection • Training • Documentation • Qualification and Validation • Market complaint / Product recall • Vendor management

3. Regulatory Expectation by organization. Effective implementation of Quality system shall include following 1. Design of robust QMS procedure for below mentioned systems The procedures to be prepared considering instructions In line with CGMPs, Comprehensive, Proactive, Science and risk-based and Accountable. • Change management • Deviation management • Effective knowledge transfer and education of the team – Training • Failure investigation – Market complaints, handling of return products • and implementation of CAPA • Document management. • Self inspection • Validation and qualification. 2. Facilitate effective knowledge transfer and management. 3. Facilitate continual improvement. 4. Establish and maintain a state of control.

4. Current status in the Facility / Requirements: A Design of robust procedure / system: Procedures are available with minimum basic GMP application - Improvement required through review in case of QMS procedures. The below mentioned procedures are to be implemented REQUIRED ON PRIORITY. • Line clearance • Process Validation • Handling of Market complaints • Product Recall • Mock Recall procedure • Failure Investigation • Batch Release • Procedure for Preparation of List of Authorized Personnel Entry to Area • Management of Data Integrity

5. Current status in the Facility / Requirements Concerns: Change management, deviation management and CAPA management. • Integrity issues. • Information - Clear communication in the QMS records are not observed. • Content writing is very weak. • Not following the required investigation tools as per the requirement. • Expectation is from QA department to execute all the QMS document – whereas it is respective department responsibility to perform the same. • In time submission of the report / QMS document is not being followed – Responsibility /Accountability lapses. • Lack of Decision-making skills – The representatives, shall always lag between middle management decision and implementation- lack of senior person involvement in the department for handling of QMS documentation. • Lack of evident investigational skills.

6. Current status in the Facility / Requirements Concerns: Self inspection. • Auditing skills is not adequate. • Lack of Decision-making skills – The representative shall always lag between middle management decision and implementation- lack of senior person involvement in the department. • Auditing is name sake. • Selecting the points to show in the report. • Lack of process knowledge. Training No physical training is occurring. Evaluation efficiency is not proper. Training calendar is not followed.

7. Current status in the Facility / Requirements Consolidated reasons: • No time to execute the QMS documentation – Other productive priorities. • Most of the errors in the Quality system is due to Manual / Human errors. • Lack of QMS knowledge – Risk based approach – thought process. • Lack of importance to the QMS system. • No designated Responsibility for QMS activity - lack of senior person involvement in department. • To many groups involving / people involved – non relevant department and mislead • No manpower for QMS. • Inadequate tracking of the QMS activity. • Lack of noticeable investigational skills. • QMS is an extra / additional job.

8. Flow chart for QMS improvement steps Phase – 1 Knowledge sharing and Accountability. Phase – II Resource management. Phase – III Self inspection / self Assessment. Phase – IV Review of procedures.

9. Implementation of QMS – Knowledge sharing and Accountability Phase – 1 • Establishment of Leadership and commitment to quality : Formation of GMP Committee and QMS Committee GMP committee includes top management like Sr. Manager and above. QMS committee includes Deputy manager and above To list all the GMP / QMS procedure. Training of all common procedures shall be classroom based – physically. Establishment of awareness of Quality concepts in the employees.Weekly training by the GMP committee to employees on QMS documentation and its importance. Understanding of QMS procedures among seniors and subordinates in the department increases. Examples of previous failures can be quoted, - helps in good understanding and feed back can be taken for improvements.

10. Accountability continued….. Phase – II or parallel. Resource management. Assessment / deputing of available manpower for QMS activities – Along with the available team nominated one manager or deputy manager is required for SME based contributions Handling of QMS documentation shall be done by the designation not les than Assistant manager. QMS committee shall work in parallel for executing QMS documentation. TCD – One month Trial Phase – III. Self inspection. – One month Phase – IV. Internal department procedure review by respective department any issues shall be brought to the notice of GMP committee and shall be resolved. Focus – GMP requirement, Practically feasible and simple to execute.

11. Management review • Effective verification of QMS trends. • Periodic review of the implementation and effectiveness of GMP through GMP committee and Sr. management • Continuous improvement – Automation of the QMS.

12. Benefits of Good QMS Meeting Patient Needs More Effectively and Efficiently Flexible Regulatory Strategies Predictability Increased Regulator Confidence

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