Procedure for Process Equipment Calibration in Manufacturing

Department	Engineering/Quality Assurance (QA)/Production
SOP No.	PE-029
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a systematic process for the calibration of manufacturing equipment used in ointment production. Regular calibration ensures accuracy, reliability, and compliance with GMP standards.

2. Scope

This SOP applies to all process equipment, including mixers, homogenizers, filling machines, temperature sensors, pressure gauges, and weighing balances, used in ointment manufacturing.

3. Responsibilities

• Engineering Team: Performs calibration as per scheduled timelines.
• Production Supervisor: Ensures equipment is available for calibration.
• QA Personnel: Verifies and approves calibration records.
• External Calibration Agency (if applicable): Conducts third-party calibration as per regulatory requirements.

4. Accountability

The Engineering and QA Managers are accountable for ensuring that calibration is conducted as per GMP and properly documented.

5. Procedure

5.1 Pre-Calibration Preparations

• Ensure the equipment is clean and in proper working condition.
• Gather calibration tools, including certified weights, thermocouples, and pressure gauges.
• Verify that calibration standards are traceable to national/international standards.

5.2 Calibration of Key Equipment

5.2.1 Weighing Balances

• Use certified standard weights to calibrate balances.
• Ensure deviations are within ±0.1% of the nominal value.
• Record the results in the Calibration Log.

5.2.2 Temperature Sensors

• Compare sensor readings with a certified reference thermometer.
• Verify that readings are within ±0.5°C tolerance.
• Document deviations and make necessary adjustments.

5.2.3 Pressure Gauges

• Calibrate using a standard pressure calibrator.
• Check readings at multiple pressure points.
• Ensure accuracy within ±0.3% of full-scale value.

5.2.4 Homogenizers and Mixers

• Measure RPM using a tachometer.
• Confirm that speed settings match the set parameters.
• Adjust control settings if deviations exceed ±2%.

5.2.5 Filling Machines

• Dispense test samples and measure weight/volume.
• Ensure the fill volume is within ±1% of the target value.
• Make necessary adjustments to maintain accuracy.

5.3 Post-Calibration Activities

• Record all calibration data in the Calibration Log.
• Affix calibration status labels on calibrated equipment.
• QA must verify and approve calibration before production resumes.

5.4 Frequency of Calibration

• Daily: Weighing balances.
• Monthly: Temperature sensors and pressure gauges.
• Quarterly: Homogenizers, mixers, and filling machines.
• Annually: Full-system calibration by external agencies.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• RPM – Revolutions Per Minute

7. Documents

• Calibration Log (Annexure-1)
• Calibration Certificate (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• ISO 17025 – Calibration and Testing Standards

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

Date	Equipment Name	Reference Standard	Deviation	Adjusted By	Verified By
01/02/2025	Weighing Balance	100g Standard Weight	±0.05g	John Doe	QA Officer
02/02/2025	Temperature Sensor	Certified Thermometer	±0.3°C	Jane Smith	QA Officer

Annexure-2: Calibration Certificate

Calibration Date	Equipment Name	Reference Standard	Final Accuracy	Certified By
01/02/2025	Pressure Gauge	ISO Standard Calibrator	±0.2%	QA Head
02/02/2025	Filling Machine	Certified Volumetric Standard	±0.9%	QA Head

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head