the Analytical Method Development laboratory for pharmaceutical API and formulation analysis.

3. Responsibilities

• Analytical Chemist: Perform calibration as per this SOP and maintain records.
• Instrument Coordinator: Ensure calibration schedule and standards are up-to-date.
• QA Officer: Review and approve calibration results and ensure instrument compliance.

4. Accountability

The Head of Analytical Method Development is accountable for implementation, review, and control of calibration activities for the UV-Visible spectrophotometer.

5. Procedure

5.1 Calibration Frequency

1. Calibration should be carried out:
   • Upon installation or relocation
   • After major repairs or software upgrade
   • Routinely at monthly intervals

5.2 Calibration Parameters

1. Wavelength Accuracy using Holmium Perchlorate solution
2. Photometric Accuracy using Potassium Dichromate solution
3. Stray Light using 1.2% Potassium Chloride solution
4. Resolution Power using Toluene in Hexane
5. Baseline Flatness and Noise Level using empty cell holders

5.3 Preparation of Calibration Standards

Prepare all calibration solutions using Class A glassware and analytical grade reagents as per Annexure-1. Use freshly prepared solutions on the day of calibration.

5.4 Calibration Execution

1. Switch on the instrument and allow it to warm up for 30 minutes.
2. Set baseline using matched quartz cells filled with distilled water.
3. Run individual tests as per the calibration checklist and record observations.

5.5 Acceptance Criteria

• Wavelength Accuracy: ±1.0 nm
• Photometric Accuracy: ±0.010 absorbance units
• Stray Light: Absorbance ≥ 2.0 at 198 nm
• Resolution: Ratio of Absorbance at 269 nm / 266 nm ≥ 1.5
• Baseline Flatness: ≤ ±0.002 Abs

5.6 Data Documentation

1. Record results in Calibration Report (Annexure-2).
2. Any deviation must be investigated and recorded using Deviation Form (Annexure-3).

5.7 Review and Approval

1. Submit calibration report to QA for review.
2. Ensure signatures of analyst, reviewer, and approver with date and time.

5.8 Labeling and Status Update

1. Affix “CALIBRATED” label with calibration and next due date.
2. Update instrument status log and master calibration schedule.

6. Abbreviations

• UV: Ultraviolet
• QA: Quality Assurance
• ICH: International Council for Harmonisation
• GMP: Good Manufacturing Practice

7. Documents

1. Annexure-1: Preparation of Calibration Standards
2. Annexure-2: Calibration Report
3. Annexure-3: Deviation Form

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• USP <857> – Ultraviolet-Visible Spectroscopy
• 21 CFR Part 211 – Subpart I: Laboratory Controls

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ankita Sharma	Priya Mehra	Dr. Ramesh Iyer
Designation	Analyst	QA Executive	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Calibration Standard Preparations

Detailed procedures for preparation of standard solutions for Holmium Perchlorate, Potassium Dichromate, Potassium Chloride, and Toluene in Hexane.

Annexure-2: UV Calibration Report

Parameter	Observed Value	Acceptance Criteria	Pass/Fail
Wavelength Accuracy	±0.6 nm	±1.0 nm	Pass
Photometric Accuracy	±0.005 AU	±0.010 AU	Pass
Stray Light	2.1 Abs	≥2.0 Abs	Pass

Annexure-3: Deviation Form

Template for deviation reporting, root cause analysis, CAPA, and final disposition of calibration failure.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Updated stray light criteria and annexure formats	Annual Review	Dr. Ramesh Iyer
15/04/2022	1.0	Initial SOP release	New SOP	QA Head