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IPQA Job Profile

E1. Line clearance activities at different processing stage-
- Dispensing
- Manufacturing
- Decartoning, Vial washing and depyrogenation
- Unit preparation area LC
- Filling/ sealing assembly
- EDMC
- Visual inspection etc
2. In- process quality assurance checks
- Area monitoring
- Filled weight
- Visual inspection and sealing quality check
- Seal integrity check or Leak test
- Machine speed and nitrogen flow rate
- Interventions monitoring
- Aseptic area practice monitoring
3. Aseptic Media Fill Simulation Study
4. Internal audit
5. SOP revision and it's training
6. Sampling at different processing stage
7. Offline NVPC monitoring and it's quarterly trending
Limit -
8. Protocol preparation and its approval
9. Batch record review and it's compliance
10. Oversight on online activity
- Assembling procedures & its flow
- Manufacturing procedures & its flow
11. AQL
Limit for manual visual inspection -
Critical -
Major -
Minor-
Limit for AQL inspection -
Critical -
Major -
Minor-
12. Reconstitution and Visual inspection
13. Batch intervention trending
14. Approval of SAP notifications
15. Reporting of incidents
16. CAPA/ Change control implementation
17. Qualification of the personnel
18. Qualified Trainer


Expiry Date (or Expiration Date): The date placed on the container/ labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions and after which date it should not be used.


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