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GMP INSPECTION REQUIREMENTS

1. Thermal Mapping of FG Store


2. Thermal Mapping of RM Store
3. Heat penetration study/Thermal Mapping of Autoclaves and Dry Heat sterilizers
4. Autoclaves validation
5. DOP test (Filter Integrity Test)
6. Calibration of production and store equipment’s i.e. Balances, Pressure Gauges,
Temperature Gauges
7. Calibration of QC and Micro lab Instruments
8. Liquid for filling in Mannometers required.

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