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Calibration & Validation
Calibration of Recording System
- All equipment and instruments used for measurements are calibrated regularly in accordance with established SOPs.
- The procedure, frequency, and responsibility for calibration are clearly defined in the SOP.
- Equipment subject to calibration includes control panels of Rapid Mixer Granulator, Fluid Bed Dryer, Octagonal Blender, etc., while instruments include HPLC, Spectrophotometer, weighing scales, electronic balances, temperature indicators/controllers, pH meters, and more.
Validation
To ensure that all instruments are properly calibrated, that all processes are reproducible, and that equipment consistently performs according to desired parameters, validation data is generated and documented. The process will be considered validated if the data describing its critical attributes meets all predefined parameters.
- Sampling of components
- Analytical testing
- Process equipment
- Equipment cleaning and calibration
- In-process control
- Packing parameters
- Environmental conditions
- Equipment designed according to Design Qualification
- Equipment validated at the time of installation (Installation Qualification)
- Following Installation Qualification, Operation Qualification and Performance Qualification are performed
- Equipment is revalidated at predetermined intervals, even when there are no changes, to ensure the process remains fully under control at all times
- Following Installation Qualification, Operation Qualification and Performance Qualification are conducted.