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

1. Identify all in-process testing equipment that requires calibration, including balances, sieves, moisture analyzers, and hardness testers.
2. Label each piece of equipment with a unique identification number for traceability.

5.2 Calibration Schedule

1. Establish a calibration schedule for all equipment based on the manufacturer’s recommendations or company-specific requirements.
2. Ensure that all equipment is calibrated before use, and re-calibrate at regular intervals, as specified by the schedule.

5.3 Calibration Procedure

1. Before calibration, ensure that the equipment is in good working condition and clean from any previous use.
2. For each piece of equipment, use certified reference standards that are traceable to national or international standards.
3. Perform calibration according to the manufacturer’s instructions or internal standard operating procedures for each type of equipment.
4. For balances: Use known weights and verify that the readings are within the acceptable tolerance range.
5. For sieves: Verify the mesh size and ensure that the sieve performs according to the specified size distribution.
6. For moisture analyzers: Use a standard material to ensure accurate moisture content readings.
7. For hardness testers: Verify the hardness values by using a reference tablet or standard material.

5.4 Recording Calibration Results

1. Document the results of the calibration in the calibration log (Annexure-2), including the equipment ID, calibration date, method used, and the results.
2. Note any deviations from the acceptable range and corrective actions taken.
3. If the equipment fails calibration, it must be taken out of service until repaired and successfully recalibrated.

5.5 Approval of Calibration Results

1. The results of the calibration must be reviewed and approved by the QA Manager or designee to confirm compliance with internal standards.
2. Any out-of-tolerance readings must be addressed before the equipment is used in the production process.

5.6 Calibration Record Retention

1. Ensure that calibration records are maintained for at least the duration specified by company policy or regulatory requirements (e.g., 3 years).
2. Store calibration records in an easily accessible and secure location for future reference or audits.

5.7 Recalibration and Maintenance

1. 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.
2. 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

1. Calibration Log (Annexure-2)
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