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 |