USDA Audit Observation found during inspection in Pharmaceutical Manufacturing Facility.
1. Calibration Planner not Update.
2. As Per Manufacturing Area/QC/ Service floor Calibration Status Tag Missing.
3. Instrument Identity not Available.
4. Instrument List Not Updated.
5. Equipment List Not Updated.
6. If Instrument is For Information (Indicative) Status Tag/ ID Not Available.
7. Instrument Master Tractability Certificate not available.
8. At the Time of Installation of HVAC System, Document is not available.
9. Drawing not updated e.g. Room name, Female Change room blending area and other Area not Updated.
10. Segregation of Drawing not available/Updated.
11. Differential Pressure segregation not Justified between Packing hall and Primary Packing cubes.
12. Engineering Change Control not Completed.
13. Calibration Execution Detail mot available.
14. No. Log book is with page Numbering.
15. The Production air Supply lacks and appropriate air filtration system.
16. No. Document Prepare i.e. o What basis we change our System from AHU running through out the day and at present only when the room is in use.
17. Document are not Signed e.g. facility and Maintenance Checklist.
18. Schedule Plan of Preventive Maintenance not Approved.
19. Tracking system of Preventive maintenance plan execution not Prepared.
20. SOP for receiving Equipment is in the plant not Available.
21. No. Issuance of Preventive Maintenance Schedule for Concern Department as per SOP.
22. Calibration Certificate issue without Control Stamp.
23. Equipment Numbering System SOP not followed.
24. Check List of Preventive Maintenance not Available like Drum mixer, Branding machine Tablet Inspection belt so need to review wit respect to equipment available as on date.
25. Engineering SOP Regarding with the Work Permit not followed, engineering Personnel follows work permit of EHS Department SOP.
26. No Document available for Plan Versa action of Preventive maintenance.
27. Running of AHU Depending upon Production needs, no document prepare for the same,as earlier all the AHUS are in Operation but because of Cost Cutting, AHU Run on Production Need.
28. Failure to maintain a backup file of data entered into the computer or related system. Regarding the 6fC'IJ I process the SCADA (Supervisory Contrnl and Data Acquisition) computer system monitors ano controls the f6l ~ I processing parameters and should there be abe1rnnt events (e.g., process failure, PC failure, instrument failure, device failure, device state failure and/or utility failure) the computer based systems electronically captures the alaimed events. The fb)('l) I operator explained that the data that is captured by the SCAD A is retained for approximately 6-months.
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