Break down handlling

Production
1

Dear Sir,
During Machine running if any breakdown happened, then how to handle it as per USFDA guidline.

2

Dear Sir,
please suggest me regarding above query

3

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.

4

After resolving the problem clean the machine acc to SCP take reline clearance and then start compression

5

Dear,

  1. Incident to be reported.
  2. Product protection.
  3. RCA & CAPA/ impact assessment.
  4. Engg. Maintenance request.
  5. Line clearance to restart.
  6. All IPC check to ensure everything is alright before full run.

Thanks

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