During Machine running if any breakdown happened, then how to handle it as per USFDA guidline.
please suggest me regarding above query
For example in case of compression Windup all the batch remove powder from hopers,feeders etc.Store batch in staging are then generate MWR(Maintenance wrk request)and send it to maintenance department.
After resolving the problem clean the machine acc to SCP take reline clearance and then start compression
- Incident to be reported.
- Product protection.
- RCA & CAPA/ impact assessment.
- Engg. Maintenance request.
- Line clearance to restart.
- All IPC check to ensure everything is alright before full run.