CALIBRATION AND VALIDATION

All manufacturing equipments and processes are validated as per the validation protocol. All testing, indicating and recording instruments are calibrated as per protocols.

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.
  • Equipments are designed as per Design Qualification.
  • Equipments are validated at the time of installation ( Installation Qualification ).
  • Subsequently Operation Qualification and Performance Qualification.
  • Such equipments 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.

FILLING / COMPRESSION / PACKING

  • All materials of previous products are removed from the area before starting next product and line clearance is obtained from Q.A. Department.
  • Product changeover on the machine & its clearing is done as per SOP.
  • Q.A. Department gives line clearance report before starting of filling / compression and packing operation. For tablets to be coated, they are coated only after Q.C. release of core tablets.
  • The coated tablets are again analyzed by Q.C. Department. After release of coated tablets, they are transferred to blister / packing section.
  • I.P.Q.C. chemist carries out weight variation, leak test and all other in process checks required to be carried out during filling / packing operations.
  • Production chemist checks the process control parameters.
  • Q.C. personnel draw sample from finished packs for testing and to preserve the required no. of packs for Control Sample.
  • Q.A. ensures that BMRs are complete in all respects. The release for sale is given by the Q.A. Manager only after complete analyses of the product as per the Standard specifications and meeting of other parameters including the documentation.
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