Team: Responsible for reviewing and approving the calibration and cleaning records, ensuring compliance with GMP standards, and taking corrective actions if necessary.

4. Accountability

The QC Manager is accountable for ensuring that cleaning and calibration activities are performed according to this SOP. The Maintenance Supervisor is responsible for overseeing the calibration process and ensuring that it adheres to the manufacturer’s requirements. The QA Manager is responsible for ensuring that the records and results comply with regulatory standards.

5. Procedure

5.1 Cleaning Procedure

1. Before starting the cleaning process, ensure that the instrument is switched off and disconnected from the power supply to prevent any electrical hazards.
2. Review the manufacturer’s cleaning instructions for each specific instrument to ensure that the proper cleaning agents and methods are used. Always use mild, non-corrosive cleaning solutions to avoid damaging the equipment.
3. Using a soft cloth or brush, clean all external parts of the instrument to remove dust, debris, and residue. Pay special attention to areas where product buildup can occur, such as spouts, sample holders, or electrical connectors.
4. If applicable, clean internal components of the instrument (e.g., sensors or probes) according to the manufacturer’s guidelines, using appropriate cleaning agents or distilled water to avoid contamination. Ensure that all internal parts are dried thoroughly before reassembling the equipment.
5. Inspect the instrument for any visible damage or wear during the cleaning process. Any damaged or worn components should be reported and replaced immediately.
6. Document the cleaning activities in the Cleaning Log (Annexure-1), including the date of cleaning, instrument name, and any maintenance or repairs performed.

5.2 Calibration Procedure

1. Ensure that the instrument is cleaned and in proper working condition before proceeding with calibration.
2. Review the manufacturer’s calibration instructions and verify that the necessary calibration standards and equipment are available.
3. For instruments such as pH meters or viscometers, calibrate using appropriate reference materials (e.g., pH buffers, viscosity standards) that are within the required range. For other instruments, refer to the manufacturer’s guidelines on calibration methods and frequency.
4. Perform calibration according to the manufacturer’s recommendations, ensuring that the instrument readings are within the specified tolerance limits. Adjust the instrument as necessary to ensure that it is operating within the correct specifications.
5. Document the calibration process in the Calibration Log (Annexure-2), including the date, calibration standard used, results, and any adjustments made. Ensure that the calibration certificate, if applicable, is filed appropriately for reference.
6. If calibration results fall outside the acceptable range, investigate the cause and take corrective actions. This may involve recalibrating the instrument or addressing any issues with the instrument itself. Document any corrective actions in the Calibration Log (Annexure-2).

5.3 Post-Inspection Activities

1. Once cleaning and calibration are completed, return the instrument to service. Ensure that it is properly reassembled and all components are in their proper positions.
2. Check the instrument’s performance by running a standard test to ensure that it is functioning within acceptable limits. Document the performance test results in the Instrument Performance Log (Annexure-3).
3. If any issues are identified during testing, take appropriate corrective actions and perform further checks as necessary.

5.4 Documentation and Record-Keeping

1. Ensure that all cleaning, calibration, and performance testing records are complete, accurate, and securely stored. This includes the Cleaning Log (Annexure-1), Calibration Log (Annexure-2), and Instrument Performance Log (Annexure-3).
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• HPLC: High-Performance Liquid Chromatography
• UV-Vis: Ultraviolet-Visible Spectrophotometer

7. Documents

1. Annexure-1: Cleaning Log
2. Annexure-2: Calibration Log
3. Annexure-3: Instrument Performance 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
• Manufacturer’s Equipment Manuals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Instrument Name	Cleaning Date	Condition	Action Taken	Operator
Viscometer	21/01/2026	Cleaned	Standard cleaning completed	John Doe

Annexure-2: Calibration Log

Instrument Name	Calibration Date	Calibrated By	Calibration Status
Viscometer	21/01/2026	Jane Smith	Passed

Annexure-3: Instrument Performance Log

Instrument Name	Performance Test Date	Test Result	Operator
Viscometer	21/01/2026	Passed	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