development laboratories. The PQ ensures the instrument meets accuracy, precision, wavelength calibration, and photometric linearity standards before being used for routine analysis or validation work.

2. Scope

This SOP applies to all UV-Visible spectrophotometers located in the Analytical Method Development (AMD) department of the pharmaceutical facility, whether used for method development, transfer, or validation projects.

3. Responsibilities

• Analytical Scientist: Conducts the PQ as per defined procedures and records the results.
• QA Personnel: Reviews the PQ data and ensures compliance with acceptance criteria.
• Instrument Coordinator: Maintains qualification schedule and tracks PQ status.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that system PQ is performed timely and accurately, and that instruments not meeting qualification requirements are not used for analytical purposes.

5. Procedure

5.1 Preparation Before Qualification

1. Ensure the instrument is installed and calibrated as per manufacturer guidelines.
2. Verify the availability of certified reference materials (CRMs), including potassium dichromate, holmium oxide filters, and neutral density filters.
3. Clean all optical paths, sample holders, and cuvettes using lint-free tissue and appropriate solvent.

5.2 Wavelength Accuracy Test

1. Use a holmium oxide filter or certified solution to verify characteristic absorbance peaks.
2. Scan from 200 nm to 600 nm.
3. Confirm absorbance peaks at certified wavelengths such as 241 nm, 279 nm, 287 nm, 361 nm, and 536 nm within ±1 nm.

5.3 Photometric Accuracy

1. Prepare a 60 mg/L solution of potassium dichromate in 0.005 M sulfuric acid.
2. Measure absorbance at 235 nm, 257 nm, 313 nm, and 350 nm using a 1 cm cell and record values.
3. Compare observed absorbance with certified values and confirm deviation is within ±0.01 A.

5.4 Stray Light Test

1. Use a 1.2% potassium chloride solution for stray light detection.
2. Set wavelength at 200 nm. The absorbance should be greater than 2.0 A.

5.5 Resolution Test

1. Scan a toluene in hexane solution (0.02% v/v) from 260 nm to 275 nm.
2. Calculate the absorbance ratio of the maxima at 269 nm and minima at 266 nm.
3. The absorbance ratio should be ≥1.5.

5.6 Linearity and Precision

1. Prepare five different concentrations of potassium permanganate or neutral density filters.
2. Record absorbance at a fixed wavelength (e.g., 530 nm).
3. Plot concentration vs. absorbance and determine R². It should be ≥ 0.999 for linearity.
4. Repeatability (RSD%) of three consecutive readings at each concentration should be ≤1.0%.

5.7 Documentation

1. Fill out the System PQ Summary Log (Annexure-1).
2. Attach scan printouts and calibration certificate copies to the logbook.
3. Submit for QA review and approval before releasing the instrument for use.

6. Abbreviations

• PQ: Performance Qualification
• UV-Vis: Ultraviolet-Visible
• CRM: Certified Reference Material
• RSD: Relative Standard Deviation
• QA: Quality Assurance

7. Documents

1. Annexure-1: System PQ Summary Log Template
2. Annexure-2: Certified Wavelength Peaks Reference Sheet
3. Annexure-3: Photometric Linearity Calibration Curve

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• Pharmacopoeia Reference: USP <857> Spectrophotometry and Light Scattering
• Instrument Manufacturer User Manuals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Shweta Mehra	Rahul Kaul	Dr. Priya Nambiar
Designation	Analyst	QA Officer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: System PQ Summary Log Template

Date	Test Performed	Acceptance Criteria	Results	Status
01/06/2025	Wavelength Accuracy	±1 nm	Pass	Pass
01/06/2025	Photometric Accuracy	±0.01 A	Pass	Pass

Annexure-2: Certified Wavelength Peaks Reference Sheet

Includes certified absorbance values and tolerance limits for holmium oxide peaks used in wavelength calibration.

Annexure-3: Photometric Linearity Calibration Curve

Graph of absorbance vs. concentration with R² value and slope, signed and dated by the analyst and reviewer.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Inclusion of Annexure formats and linearity validation criteria	Periodic SOP revision	Dr. Priya Nambiar
10/07/2022	1.0	Initial version	New SOP implementation	QA Head