Standard Operating Procedure for Calibration of In-Process Testing Equipment
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/149/2025 |
| Supersedes | SOP/TAB/149/2022 |
| 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 a procedure for the calibration of in-process testing equipment used during tablet production to ensure accurate and reliable measurement results in compliance with GMP standards.
2. Scope
This SOP applies to the calibration of all in-process testing equipment used during tablet manufacturing, including but not limited to equipment used for measuring particle size, moisture content, hardness, and weight.
3. Responsibilities
- Quality Control (QC): Responsible for performing calibration of testing equipment and ensuring that all calibration records are maintained and up to date.
- Equipment Operator: Responsible for ensuring the equipment is used according to specifications and notifying QC when calibration is required.
- Maintenance Department: Responsible for assisting with any equipment repairs or malfunctions that may affect calibration results.
- Quality Assurance (QA): Ensures that calibration activities are compliant with SOPs and reviews the calibration records.
4. Accountability
The QC Manager is accountable for ensuring that all in-process testing equipment is calibrated regularly and accurately. The QA Manager is responsible for reviewing the calibration records and ensuring compliance with relevant standards.
5. Procedure
5.1 Equipment Identification
- Identify all in-process testing equipment that requires calibration, including balances, sieves, moisture analyzers, and hardness testers.
- Label each piece of equipment with a unique identification number for traceability.
5.2 Calibration Schedule
- Establish a calibration schedule for all equipment based on the manufacturer’s recommendations or company-specific requirements.
- Ensure that all equipment is calibrated before use, and re-calibrate at regular intervals, as specified by the schedule.
5.3 Calibration Procedure
- Before calibration, ensure that the equipment is in good working condition and clean from any previous use.
- For each piece of equipment, use certified reference standards that are traceable to national or international standards.
- Perform calibration according to the manufacturer’s instructions or internal standard operating procedures for each type of equipment.
- For balances: Use known weights and verify that the readings are within the acceptable tolerance range.
- For sieves: Verify the mesh size and ensure that the sieve performs according to the specified size distribution.
- For moisture analyzers: Use a standard material to ensure accurate moisture content readings.
- For hardness testers: Verify the hardness values by using a reference tablet or standard material.
5.4 Recording Calibration Results
- Document the results of the calibration in the calibration log (Annexure-2), including the equipment ID, calibration date, method used, and the results.
- Note any deviations from the acceptable range and corrective actions taken.
- If the equipment fails calibration, it must be taken out of service until repaired and successfully recalibrated.
5.5 Approval of Calibration Results
- The results of the calibration must be reviewed and approved by the QA Manager or designee to confirm compliance with internal standards.
- Any out-of-tolerance readings must be addressed before the equipment is used in the production process.
5.6 Calibration Record Retention
- Ensure that calibration records are maintained for at least the duration specified by company policy or regulatory requirements (e.g., 3 years).
- Store calibration records in an easily accessible and secure location for future reference or audits.
5.7 Recalibration and Maintenance
- Perform recalibration if the equipment is found to be out of tolerance, after any maintenance or repairs, or if it has been relocated or exposed to extreme conditions.
- Ensure that equipment is re-calibrated before being placed back into service.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
7. Documents
- Calibration Log (Annexure-2)
- Calibration Certificate (Annexure-3)
8. References
- USP <41> – Calibration of Laboratory Equipment
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Report
| Deviation Date | Equipment ID | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Balance-01 | Out of tolerance for weight measurement | Recalibrated and tested successfully | John Doe |
Annexure-2: Calibration Log
| Equipment ID | Calibration Date | Test Method | Result | Next Calibration Due |
|---|---|---|---|---|
| Balance-01 | 01/01/2026 | Weight Calibration | Passed | 01/01/2027 |
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 procedure | Improved compliance requirements | QA Head |