Standard Operating Procedure for Calibration & Verification of Hardness Tester:
Purpose
The purpose of this SOP is to provide detailed guidelines for the calibration and verification of the hardness tester in pharmaceutical manufacturing. Calibration and verification ensure the accuracy and reliability of hardness measurements, ensuring compliance with regulatory requirements and maintaining the highest standards of product quality.
Scope
This SOP applies to all personnel involved in the calibration and verification of the hardness 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 performing the calibration and verification of the hardness tester.
Procedure
Preparation
- Ensure that the hardness tester is clean and free from any dust or contaminants that may affect the calibration.
- Verify that all required calibration standards and reference materials are available and traceable to a national or international standard.
- Ensure that the hardness 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 hardness tester or follow the recommended calibration frequency based on the manufacturer’s instructions.
- Adjust the hardness tester to match the reference hardness 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 hardness tester to ensure its ongoing accuracy and precision.
- Use the reference materials with known hardness values to verify the hardness tester readings.
- Compare the hardness 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 hardness 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
- Hardness Tester Calibration Log
- Hardness 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 Hardness Tester.