Standard Operating Procedure for
Calibration & Verification of Disintegration Tester

Purpose

The purpose of this SOP is to establish comprehensive guidelines for the calibration and verification of the disintegration tester in pharmaceutical manufacturing. Calibration and verification ensure the accuracy and reliability of disintegration test results, leading to confident decisions on product quality and adherence to regulatory requirements. This SOP aims to maintain the highest standards of excellence in the pharmaceutical production process and foster a culture of continuous improvement.

Scope

This SOP applies to all personnel involved in the calibration and verification of the disintegration tester within the pharmaceutical company.

Responsibilities

• The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
• The Production department is responsible for conducting the calibration and verification of the disintegration tester.

Procedure

Preparation

• Ensure that the disintegration tester is clean and free from any debris that may impact the calibration process.
• Verify that all required calibration standards and reference materials are available and traceable to a national or international standard.
• Check that the disintegration tester is connected to a stable power source and properly grounded.
• Review the manufacturer’s guidelines and specifications for the calibration and verification process.

Calibration

• Perform the initial calibration of the disintegration tester or follow the recommended calibration frequency based on the manufacturer’s instructions.
• Adjust the disintegration tester to match the reference disintegration values using the calibration standards.
• Record the calibration details, including the date, calibration standards used, and results obtained.
• If any deviations are observed during the calibration process, take corrective actions promptly and re-calibrate as necessary.

Verification

• Perform regular verification checks on the disintegration tester to ensure its ongoing accuracy and precision.
• Use the reference materials with known disintegration times to verify the tester’s readings.
• Compare the disintegration tester readings with the known reference values and record the verification results.
• If any discrepancies are identified during verification, take appropriate corrective actions and re-verify the disintegration tester.

Documentation

• Maintain comprehensive records of all calibration and verification activities.
• Document any adjustments, deviations, or corrective actions taken during the calibration and verification process.
• Retain calibration and verification records for the required period as per the company’s document retention policy.

Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Disintegration Tester Calibration Log
• Disintegration Tester Verification Log

References

No specific references are applicable for this SOP.

SOP Version

This is version 1.0 of the SOP for Calibration and Verification of Disintegration Tester.