Calibration & Validation

Calibration of Recording System

  • All equipments/instruments that are used to carry out measurement are calibrated as per SOPs at regular intervals
  • The procedure, frequency and responsibility of calibration are defined in the SOP
  • Such equipments include control panels of Rapid Mixer Granulator, Fluid Bed Drier, Octagonal Blender, etc. and the instruments include HPLC, Spectrophotometer, Weighing Scales, Electronic Balances, Temperature Indicators/Controllers, pH meter etc

Validation

With a view to ensure that all instrument are appropriately calibrated, all the processing is reproducible and all the equipments perform consistently as per the desired parameters, validation data is generated and recorded. The process shall be deemed validated if the data describing its critical attributes meets all the pre-determined parameters.

  • SOME OF THE CRITICAL PARAMETERS ARE:
    • Sampling of components
    • Analytical testing
    • Process equipment
    • Equipment cleaning and calibration
    • In-process control
    • Packing parameters
    • Environmental conditions
    • Equipment are designed as per Design Qualification
    • Equipment are validated at the time of installation ( Installation Qualification )
    • Subsequently Operation Qualification and Performance Qualification
    • Such equipment are revalidated at a predetermined frequency even when there is no change to ensure that the process is fully under control at all times
    • Subsequently Operation Qualification and Performance Qualification