PDH Pharmaceuticals Pvt.Ltd

Calibration & Validation

Overview

  • The quality control department is responsible for the internal calibration of testing and measuring equipment according to the SOPs for the calibration of concerned equipment.
  • External calibration is concerned by the authorized contractor according to the schedule.
  • A calibration schedule for the internal and external calibration of all measuring equipment has been prepared.
  • All the calibration documents prepared internally and provided by the external body are well maintained and the equipment is labeled with a calibration status indicating sticker.
  • The testing methods are validated before application according to international standards and the record is kept properly.
  • Various parameters used for the validation of testing methods are linearity, range, quantitative limits, specificity, accuracy, detection limits, and robustness.

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