SOP applies to all measuring, monitoring, and controlling equipment used in the manufacturing of pharmaceutical gel products at the production site, including but not limited to balances, pH meters, temperature controllers, pressure gauges, and homogenizers.

3. Responsibilities

• Production Personnel: Identify equipment due for calibration and inform QA/Engineering.
• Engineering Department: Perform or coordinate calibration activities, maintain calibration standards.
• Quality Assurance: Verify calibration, maintain records, and audit compliance.

4. Accountability

The Head – Manufacturing shall be accountable for implementation, monitoring, and training on this SOP.

5. Procedure

5.1 Identification of Equipment

1. Maintain an updated list of all equipment requiring calibration in the Calibration Master List.
2. Assign a unique Equipment ID and calibration frequency based on criticality.

5.2 Calibration Schedule

1. Prepare an annual calibration schedule in coordination with QA.
2. Display the monthly calibration calendar in the Engineering office and production area.

5.3 Calibration Execution

1. Use only certified and traceable calibration standards/instruments.
2. Ensure equipment is clean and functional before calibration.
3. Document pre-calibration readings where applicable.
4. Carry out calibration as per manufacturer guidelines or approved internal SOPs.
5. Record results and observations in Annexure-1.

5.4 Calibration Acceptance Criteria

• Each parameter must fall within the specified tolerance limits.
• In case of failure, initiate deviation and investigate possible impact on batches.
• Mark calibrated equipment with a “Calibrated” tag with date and due date.

5.5 Post-Calibration Actions

1. Update calibration status in the Equipment History Card.
2. Remove “Out of Calibration” labels after successful calibration.
3. QA to review and approve calibration records within 3 working days.

5.6 Handling Out-of-Tolerance (OOT) Results

1. Segregate and label equipment with “Out of Calibration” status.
2. QA to initiate deviation report and conduct impact assessment for all batches affected.
3. Rectify, repair, or replace equipment as needed and recalibrate before reuse.

5.7 Documentation and Record Maintenance

• All records must be completed in blue ink, legible, and without overwriting.
• Maintain calibration certificates and Annexure-1 for at least 5 years.

6. Abbreviations

• GMP: Good Manufacturing Practice
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• OOT: Out of Tolerance

7. Documents

1. Calibration Master List
2. Equipment History Card
3. Deviation Log Book
4. Calibration Certificate
5. Calibration Record Sheet – Annexure-1

8. References

• ICH Q7: GMP Guidelines for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – US FDA GMP Regulations

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Calibration Record Sheet

Date	Equipment ID	Equipment Name	Calibrated Parameter	Standard Used	Pre-Reading	Post-Reading	Calibrated By	Verified By	Remarks

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Format updates and annexure added	Periodic Review	QA Head