any issues that may require repair or replacement.

Quality Assurance (QA) Team: Responsible for reviewing and approving the calibration results and ensuring that the calibration process complies with GMP and regulatory standards.

Production Team: Responsible for reporting any abnormal pressure readings that may indicate a malfunction in the pressure gauges, and for ensuring that pressure levels are within acceptable limits during production.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all pressure gauges are calibrated according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Calibration

1. Ensure that the pressure gauge is free from damage and functioning properly. Verify that the gauge is connected to the utility system and is in the appropriate condition for calibration.
2. Verify that the necessary calibration equipment is available and properly calibrated. This includes comparison standards, calibration kits, and pressure sources such as hand pumps or calibration rigs.
3. Review the manufacturer’s specifications for the pressure gauge to determine the calibration range and tolerances required for the specific application.
4. Establish the calibration team, which should include representatives from the Engineering, Maintenance, and QA teams. Ensure that personnel are trained in calibration procedures and understand the required standards.
5. Ensure that the calibration area is clean and free of any contaminants that could affect the calibration process. All instruments and equipment should be properly labeled and easily identifiable.

5.2. Performing the Calibration

1. Begin the calibration process by verifying the zero reading of the pressure gauge. This ensures that the gauge reads accurately when there is no pressure applied.
2. Apply a known reference pressure to the gauge being calibrated. Use a calibrated pressure source, such as a pressure calibrator or dead weight tester, to ensure that the applied pressure is accurate.
3. Record the reading on the pressure gauge at multiple pressure points within the specified range. Compare the gauge’s readings with the reference pressure and verify that they are within the acceptable tolerance limits.
4. If the readings are outside the tolerance limits, adjust the pressure gauge according to the manufacturer’s instructions to bring it into alignment with the reference pressure.
5. Repeat the process for multiple pressure points (e.g., low, medium, and high pressure) to ensure accuracy across the entire range of the pressure gauge.
6. If the pressure gauge cannot be calibrated to the specified tolerance limits, report the issue and remove the gauge from service for repair or replacement.

5.3. Documenting the Calibration Results

1. Document the calibration results in the Calibration Record (Annexure-1). The record should include the following information:
   • Pressure gauge ID, model number, serial number, and location
   • Calibration date and time
   • The reference pressure values applied during calibration and the readings of the gauge at each pressure point
   • Any deviations observed during calibration and corrective actions taken (if applicable)
   • The name and signature of the personnel performing the calibration
   • Approval signatures from the QA team
2. Ensure that all calibration results are accurate, complete, and easy to review. Any deviations from the expected results should be thoroughly documented and addressed.

5.4. Reviewing and Approving the Calibration Report

1. The QA team should review the Calibration Record to ensure that all calibration activities were performed according to this SOP and that the gauge is operating within the specified tolerance limits.
2. If any deviations were observed during calibration, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken to address the issue.
3. The QA team should approve the calibration report once all tests are complete and any deviations have been addressed.

5.5. Finalizing the Calibration Process

1. Once the calibration is complete, the pressure gauge is returned to service and marked with the calibration date and the next due date for re-calibration.
2. Ensure that all documentation, including the Calibration Record, Deviation Log, and any corrective actions, is archived for future audits and inspections.
3. Periodic re-calibration of pressure gauges should be scheduled as per the manufacturer’s recommendations or regulatory requirements to ensure continuous accuracy.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• OQ: Operational Qualification
• PQ: Performance Qualification
• IQ: Installation Qualification

7. Documents

1. Calibration Record (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001: Quality Management Systems

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 Record

Gauge ID	Model Number	Serial Number	Test Date	Pressure Point (psi)	Gauge Reading (psi)	Deviation	Corrective Action
PG-001	Model A	SN123456	06/02/2025	30	29.8	0.2 psi	Adjust calibration
PG-001	Model A	SN123456	06/02/2025	60	59.9	0.1 psi	Adjust calibration

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Pressure deviation at 30 psi	Recalibrated gauge	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Recalibrated pressure gauge	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated calibration procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures