QUALITY MANAGEMENT SYSTEM
1. Handling of change control
2. Handling of Deviation
3. Handling of Incidence
4. Handling of CAPA
5. Handling of OOS
6. Handling of OOT
7. Handling of Market Complaint
8. Handling of product Recall
9. Conducting of Self Inspection
10. Preparation of Risk assessment
11. Review of Batch Record
12. Releasing of Batch
13. Approval of BMR. BPR, MFC,MPC
14. Qualification of Vendor
15. Review of SOP
16. Document control.
17. Preparation of APQR
VALIDATION ACTIVITY
1. Preparation of VMP
2. Preparation of validation protocol
3. Facility Qualification
4. Utility qualification (Preparation of Protocol, Preparation of Report review of raw data)
5. Equipment qualification
6. Cleaning validation
7. Verification of Preventive Maintenance
8. Verification of calibration of all instrument / Equipment
9. Personal Qualification
10. Trend Verification
11. Aseptic Process Simulation Activity
12. Review of validation SOP.
13. Verify all activity of engineering QA.