Standard Operating Procedure for Calibration of Critical Equipment in Tablet Manufacturing
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/178/2025 |
| Supersedes | SOP/TAB/178/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To establish procedures for the calibration of critical equipment used in tablet manufacturing, ensuring that equipment performs according to required specifications and that the tablets produced meet quality and regulatory standards.
2. Scope
This SOP applies to all critical equipment used in tablet manufacturing, including tablet compression machines, coating machines, granulators, mixers, and other equipment that affect the quality and consistency of the product.
3. Responsibilities
- Quality Assurance (QA): Responsible for overseeing the calibration process, ensuring compliance with regulatory requirements, and reviewing calibration records.
- Maintenance Team: Responsible for carrying out the calibration activities, ensuring that equipment is calibrated at regular intervals, and maintaining calibration tools and standards.
- Production Supervisors: Ensure that all equipment is calibrated before use and that any out-of-specification equipment is reported for corrective action.
- Technicians: Responsible for performing equipment calibration, recording results, and following the calibration procedures as defined in this SOP.
4. Accountability
The QA Manager is accountable for ensuring that calibration procedures are followed, that the necessary tools and standards are available, and that all records are maintained. The Maintenance Supervisor is accountable for the execution of calibration activities.
5. Procedure
5.1 Calibration Frequency
- Critical equipment must be calibrated at predefined intervals, typically at least once a year, or as per the manufacturer’s specifications. If any equipment is found to be out of tolerance, recalibration must be conducted.
- Calibration frequency may be adjusted based on equipment usage, operational conditions, or any deviations observed during previous calibration checks.
- Equipment calibration must be scheduled in coordination with the production team to minimize downtime and ensure compliance with production timelines.
5.2 Calibration Tools and Standards
- Ensure that all calibration tools and standards used are traceable to national or international standards, such as ISO or NIST, and are regularly calibrated themselves.
- Calibration tools should be certified for accuracy and maintained according to the manufacturer’s recommendations.
- Use appropriate tools for each equipment type, such as pressure gauges for tablet compression machines, thermometers for temperature monitoring, and weigh scales for weight uniformity tests.
5.3 Calibration Procedure
- Before calibration, ensure that the equipment is clean and free of any contaminants that could affect calibration results.
- Perform calibration checks in accordance with the manufacturer’s instructions or established in-house procedures. This may include measuring key parameters such as weight, speed, pressure, temperature, and other critical variables.
- Compare the measured values with the manufacturer’s specifications or established tolerances. If the values are within the specified limits, the equipment is considered calibrated.
- If the equipment is found to be out of specification, adjust the equipment to meet the required parameters. Perform verification to ensure the adjustment is correct and that the equipment is functioning within its specifications.
- Record all calibration activities, including the equipment identification, calibration date, the parameters tested, the results, any adjustments made, and the technician’s name (Annexure-1).
5.4 Calibration Records
- Maintain a detailed calibration log for each piece of equipment. The log should include the following information:
- Equipment ID
- Calibration date
- Calibration results (e.g., measured values vs. acceptable range)
- Corrective actions taken (if any)
- Signature of the technician performing the calibration
- Calibration records must be reviewed by the QA department and retained for a minimum of five years or as per regulatory requirements (Annexure-2).
5.5 Recalibration and Corrective Actions
- If equipment fails to meet calibration specifications, initiate corrective actions immediately. This may involve recalibration, repair, or replacement of faulty components.
- Upon recalibration or corrective actions, retest the equipment to ensure that it is operating within the specified limits. Document the results and update the calibration records accordingly.
- If necessary, investigate the root cause of the failure and implement preventive actions to avoid future occurrences.
5.6 Calibration Equipment and Maintenance
- All calibration equipment, such as test weights, pressure gauges, thermometers, and flow meters, must be regularly maintained and calibrated themselves according to the manufacturer’s recommendations or industry standards.
- Calibration equipment should be stored in a clean and controlled environment to prevent damage and ensure accuracy during use.
5.7 Equipment Performance Monitoring
- Once equipment is calibrated, monitor its performance regularly to ensure that it remains within the defined tolerances. If any deviations are noted during routine use, initiate recalibration as necessary.
- Regularly review equipment performance data to identify trends or recurring issues that may indicate the need for more frequent calibration or corrective actions.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- NIST: National Institute of Standards and Technology
- ISO: International Organization for Standardization
7. Documents
- Calibration Record Log (Annexure-1)
- Calibration Equipment Maintenance Log (Annexure-2)
8. References
- ISO 9001 – Quality Management Systems
- ISO 10012 – Measurement Management Systems – Requirements for Measurement Processes and Measuring Equipment
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
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 Log
| Equipment ID | Calibration Date | Calibration Results | Corrective Actions Taken | Technician |
|---|---|---|---|---|
| Comp-12345 | 01/01/2026 | Within tolerance | None | John Doe |
Annexure-2: Calibration Equipment Maintenance Log
| Calibration Equipment ID | Last Calibration Date | Next Calibration Date | Maintenance Performed |
|---|---|---|---|
| Pressure Gauge-1 | 01/12/2025 | 01/12/2026 | Recalibrated and cleaned |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated calibration procedures | Improved calibration frequency and maintenance steps | QA Head |