generation.

2. Scope

This procedure applies to all UV-Visible spectrophotometers used in the Analytical Method Development (AMD) laboratory for research, method validation, and stability studies.

3. Responsibilities

• Analyst: Performs the qualification testing and documentation.
• Engineering: Supports in installation and maintenance of utilities.
• QA Officer: Reviews and approves the qualification report.
• Department Head: Ensures timely qualification and regulatory compliance.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that all UV-Visible spectrophotometers are qualified prior to routine use and requalified after any critical maintenance or system upgrade.

5. Procedure

5.1 Qualification Stages

1. Design Qualification (DQ): Define functional requirements and ensure selected instrument matches the intended purpose.
2. Installation Qualification (IQ): Verify proper installation and integration of instrument, software, and utilities.
3. Operational Qualification (OQ): Confirm system performance under defined conditions using certified standards.
4. Performance Qualification (PQ): Verify that instrument performs consistently during typical use with known substances.

5.2 Installation Qualification (IQ)

1. Inspect equipment against specifications and purchase documents.
2. Check power supply, LAN, software installation, and user access configuration.
3. Record instrument details (model, serial number, software version) in Annexure-1.

5.3 Operational Qualification (OQ)

1. Perform wavelength accuracy check using holmium oxide filter (±1 nm).
2. Evaluate photometric accuracy using potassium dichromate solution.
3. Test stray light using sodium nitrite or potassium chloride as per pharmacopeia.
4. Log results in Annexure-2 and verify against manufacturer specifications.

5.4 Performance Qualification (PQ)

1. Analyze certified reference material (e.g., USP standard) and measure absorbance at specified wavelengths.
2. Verify system precision over multiple replicates (%RSD < 1%).
3. Document test conditions, observations, and final results in Annexure-3.

5.5 Requalification Requirements

• Annual requalification as per master schedule.
• Requalification post-major repair, part replacement, or software upgrade.
• Unplanned downtime exceeding 30 days.

5.6 Documentation and Reporting

1. Compile IQ, OQ, and PQ reports along with calibration certificates.
2. Attach supporting data, test protocols, and graphical results.
3. Submit compiled qualification report to QA for final approval and filing.

6. Abbreviations

• UV-Vis: Ultraviolet-Visible
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• %RSD: Relative Standard Deviation

7. Documents

1. Annexure-1: Installation Qualification Checklist
2. Annexure-2: Operational Qualification Data
3. Annexure-3: Performance Qualification Records
4. Annexure-4: Final Qualification Summary Report

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• USP General Chapter <857> – Ultraviolet-Visible Spectroscopy
• 21 CFR Part 11 – Electronic Records and Signatures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Sunita Deshmukh	Karan Mehta	Dr. Isha Malhotra
Designation	Analyst	QA Officer	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: IQ Checklist

• Equipment Details (Model, Serial No., Manufacturer)
• Power Backup Verification
• Software and Firmware Versions

Annexure-2: OQ Data

Test	Standard	Result	Status
Wavelength Accuracy	241.1 nm (±1 nm)	240.9 nm	Pass
Photometric Accuracy	0.745 ± 0.01	0.743	Pass

Annexure-3: PQ Records

• Analyte: Potassium Dichromate
• Absorbance Mean: 0.744
• %RSD: 0.8%

Annexure-4: Qualification Summary

All qualification steps were completed satisfactorily, and the UV-Visible Spectrophotometer is approved for use in analytical applications.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Revised PQ criteria and included updated annexures	Annual SOP Review	Dr. Isha Malhotra
15/06/2022	1.0	Initial Release	New Equipment Qualification SOP	QA Head