The Laboratory Supervisor is responsible for supervising the calibration process and ensuring that it is completed as required. The Maintenance Team is responsible for repairing or servicing the equipment as necessary.

5. Procedure

5.1 Pre-Calibration Preparation

1. Ensure that the viscometer is clean and free of any residue or contamination from previous tests.
2. Verify that all necessary calibration standards and reference materials are available and within their expiration dates.
3. Ensure that the viscometer is set up in a clean, controlled environment, free from vibration, temperature fluctuations, or any other factors that could affect its performance.
4. Check the equipment for proper functioning and ensure that any issues such as malfunctions or wear and tear are addressed before calibration.

5.2 Calibration Procedure

1. Select the appropriate calibration standards based on the viscosity range expected for the cream formulations being tested.
2. For manual viscometers, fill the sample container with the calibration fluid or standard and attach it to the viscometer. For automated viscometers, ensure that the standard fluid is loaded into the instrument according to the manufacturer’s instructions.
3. Perform the calibration according to the manufacturer’s guidelines, ensuring that the instrument is measuring viscosity correctly. The procedure typically involves comparing the readings from the viscometer with the known values of the calibration fluid.
4. Record the readings from the viscometer and compare them with the expected values for the standard fluid. Any deviation from the expected values must be within the acceptable range specified by the manufacturer or regulatory standards.

5.3 Post-Calibration Checks

1. If the calibration results are within the acceptable range, the viscometer is considered calibrated and ready for use.
2. If the calibration results are outside the acceptable range, recalibrate the instrument using a different calibration fluid or check for any issues with the equipment (e.g., malfunctioning parts, improper setup).
3. Record the calibration results, including the date, calibration fluid used, calibration values, and any corrective actions taken, in the Calibration Log (Annexure-1).
4. If any corrective actions are needed, perform them and repeat the calibration process to ensure the instrument meets the required specifications.

5.4 Equipment Maintenance

1. Ensure that the viscometer is properly maintained following the manufacturer’s maintenance schedule. Regular maintenance will ensure that the instrument continues to perform accurately and consistently.
2. Schedule regular preventive maintenance and calibration checks as part of a routine maintenance program.
3. Ensure that any malfunctioning equipment is repaired promptly, and calibration records are updated accordingly.

5.5 Documentation and Record-Keeping

1. Document all calibration results, including any deviations, in the Calibration Log (Annexure-1). This includes both successful and unsuccessful calibration attempts.
2. Ensure that all calibration records are signed off by the person performing the calibration and reviewed by the Laboratory Supervisor.
3. Maintain calibration records for a minimum of two years or as required by regulatory guidelines.
4. Ensure that all records are securely stored and readily available for review during internal audits or regulatory inspections.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Calibration Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Viscometer Manufacturer’s Calibration Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Calibration Log

Viscometer ID	Calibration Date	Calibration Fluid	Measured Viscosity	Expected Viscosity	Deviation	Operator
VM-001	21/01/2026	Standard Fluid A	85 cP	80 cP	5 cP	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head