GMP Working

1. Thermal Mapping of FG Store

2. Thermal Mapping of RM Store
3. DOP Test of HVAC
4. Heat penetration study/Thermal Mapping of Autoclaves and Dry Heat sterilizers
5. Autoclaves validation
6. Calibration of production and store equipment’s i.e. Balances, Pressure Gauges,
Temperature Gauges
7. Calibration of QC and Micro lab Instruments
8. Installation of Pressure Differential Gauges in liquid Injections.
9. Liquid for filling in Manometers required.
10. If possible, Installation of HVAC connection in Main corridor
11. If possible, Installation of AC connection in executive entry
12. Proper arrangement of Packaging material in Packaging material store i.e everything
must be arranged in proper manner, Labels and Unitcartons in Shippers, HDPE Bottles in
proper PVC packing. No bags of Urea or any prohibited items for packing material
allowed.
13. Liquid Material store also be arranged.
14. Empty Drums/discarded items must be sold.
15. Cleaning of all areas i.e Reception, Executive entry, Main corridor, all sections, QC Lab,
Stores, packing hall, Changes rooms required before inspection
16. Process validation protocol and reports
17. Method validation protocol and reports
18. Stability protocols and stability data
19. Cleaning validation protocol and reports
20. HVAC Validation
21. DI and Distillation plant qualification