performing the calibration of weighing balances and documenting the calibration results.

Production Manager: Ensures that calibration procedures are followed by all relevant personnel and that any discrepancies are reported and resolved.

4. Accountability

The Warehouse Manager is accountable for ensuring that this SOP is followed and that any deviations are addressed promptly. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Calibration Frequency

1. Weighing balances used in dispensing areas must be calibrated at least once every six months or whenever there is a significant change in the equipment (e.g., after repair, maintenance, or relocation).
2. Additionally, balances should be recalibrated after any event that could potentially affect accuracy, such as exposure to extreme environmental conditions or mechanical shock.

5.2. Calibration Process

1. The calibration should be performed by qualified personnel who are trained in the calibration procedures for weighing balances.
2. Before calibration, ensure that the weighing balance is clean and free from any residue, dust, or other contaminants.
3. Use certified calibration weights of known mass to perform the calibration. These weights should be traceable to national or international standards.
4. Follow the manufacturer’s instructions for the calibration procedure. This will include adjusting the balance if necessary to ensure that it reads correctly at zero and at the various test points.
5. Record the calibration results, including the weight used for calibration, the balance’s readings, the deviation from the expected values, and any corrective actions taken, if applicable.

5.3. Calibration Documentation

1. Maintain a Calibration Log (Annexure-1) for each weighing balance. The log should include the following details:
   • Equipment ID and description
   • Calibration date
   • Calibration results (weights used, deviations, corrective actions, etc.)
   • Personnel performing the calibration
   • Next calibration due date
2. The Calibration Log should be signed by the personnel performing the calibration and reviewed by the QC team to ensure compliance with the SOP.
3. If a weighing balance fails calibration, it must be removed from service until it has been repaired or recalibrated. The failure and corrective action must be documented in the Calibration Log.

5.4. Verification of Calibration

1. The QC team will verify the calibration results by reviewing the Calibration Log and checking that the balance is reading within the specified tolerance limits.
2. Occasionally, QC should perform verification using certified calibration weights to ensure that the balance continues to meet accuracy standards between scheduled calibrations.
3. Any discrepancies found during verification should be addressed immediately, including recalibrating the balance or taking corrective actions if necessary.

5.5. Equipment Maintenance

1. Ensure that all weighing balances are kept in good working condition and are properly maintained to prevent mechanical failures that could affect the accuracy of weighing results.
2. Schedule regular maintenance of the equipment, including cleaning and lubricating parts as necessary, to ensure reliable performance.
3. Document all maintenance activities in the Equipment Maintenance Log (Annexure-2) and ensure that the equipment is functioning properly before use.

5.6. Corrective and Preventive Actions (CAPA)

1. In case of a calibration failure or verification discrepancy, a corrective action should be implemented immediately. This may include recalibrating the balance, repairing the equipment, or replacing faulty components.
2. Preventive actions should be taken to minimize the risk of future calibration issues, such as additional staff training, improved equipment handling protocols, or enhanced monitoring of environmental conditions in the dispensing area.
3. Document all corrective and preventive actions in the CAPA Log (Annexure-3) and ensure that follow-up verification is conducted to confirm the effectiveness of the actions taken.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions

7. Documents

1. Calibration Log (Annexure-1)
2. Equipment Maintenance Log (Annexure-2)
3. CAPA Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

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

Equipment ID	Calibration Date	Calibration Result	Next Calibration Due	Performed By
WB-001	01/01/2025	Pass	01/07/2025	Ravi Kumar

Annexure-2: Equipment Maintenance Log

Equipment ID	Maintenance Date	Maintenance Description	Performed By
WB-001	01/01/2025	Cleaned and lubricated	Rajesh Patel

Annexure-3: CAPA Log

Issue	Root Cause	Corrective Action	Preventive Action	Follow-up Date
Calibration failure	Incorrect weight used	Recalibrated balance	Reviewed calibration procedure	06/03/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated calibration procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures