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...