manufacturing.

2. Scope

This SOP applies to all analytical instruments and laboratory equipment utilized within the QA labs for testing, verification, and quality assessments of sterile injectable products.

3. Responsibilities

• QA Lab Analysts: Operate calibrated instruments as per the latest calibration status.
• QA Calibration Coordinator: Schedule, coordinate, and verify calibration activities.
• External Calibration Vendors: Perform calibration as per applicable standards (if outsourced).
• Engineering/Maintenance: Assist in equipment preparation and troubleshooting.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that all laboratory instruments are calibrated within the defined frequency and maintained as per GMP standards.

5. Procedure

5.1 Preparation for Calibration

1. Prepare an annual calibration schedule for all QA instruments and get it approved by QA Head.
2. Ensure instruments are clean, functional, and free from sample residues before calibration.
3. Refer to the previous calibration report (Annexure-1) to check past results and non-conformities.

5.2 Calibration Execution

1. Perform calibration using certified reference standards traceable to national/international bodies.
2. Record readings before and after calibration (as found/as left) in Calibration Worksheet (Annexure-2).
3. If deviations are found, label instrument as “OUT OF CALIBRATION” and withdraw from use.
4. Acceptable calibration tolerance shall be defined in individual instrument SOPs.

5.3 Labeling and Documentation

1. Affix a “CALIBRATED” label with:
   • Calibration Date
   • Next Due Date
   • Calibration Reference Number
2. Update the Calibration Status Log (Annexure-3) upon completion of calibration.

5.4 Handling Out-of-Tolerance (OOT) Instruments

1. If the instrument fails calibration:
   • Initiate deviation as per SOP on OOT results.
   • Assess impact on data generated since last calibration.
   • Perform corrective and preventive actions (CAPA).

5.5 Review and Approval

1. QA Calibration Coordinator verifies calibration certificates.
2. Certificates are filed with corresponding equipment ID and stored for 5 years.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• OOT: Out of Tolerance
• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practice

7. Documents

1. Previous Calibration Report – Annexure-1
2. Calibration Worksheet – Annexure-2
3. Calibration Status Log – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• ISO 17025 – General requirements for the competence of testing and calibration laboratories
• 21 CFR Part 211.68 – Automatic, Mechanical, and Electronic Equipment

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Previous Calibration Report

Instrument Name	Equipment ID	Last Calibration Date	Status
HPLC	QA/HPLC/004	05/06/2024	Pass

Annexure-2: Calibration Worksheet

Instrument	Parameter	As Found	As Left	Tolerance	Status
Balance	Weight	100.2g	100.0g	±0.1g	Pass

Annexure-3: Calibration Status Log

Instrument	Calibration Date	Due Date	Status	Calibrated By
pH Meter	10/06/2025	10/06/2026	Calibrated	Ravindra Joshi

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
05/06/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Clarified labeling, documentation, and added OOT handling	Review Cycle	QA Head