complies with regulatory standards for spectral accuracy, reproducibility, and baseline performance before it is used for sample analysis.

2. Scope

This procedure is applicable to all FTIR spectrophotometers used within the AMD department, including those designated for routine sample analysis, method validation, and raw material identification.

3. Responsibilities

• Analytical Scientist: Conducts PQ checks and records results in prescribed templates.
• QA Executive: Reviews PQ data for compliance and authorizes release of instrument for analytical use.
• Instrument Coordinator: Maintains PQ schedule and calibration history.

4. Accountability

The Head of Analytical Method Development is responsible for ensuring that all FTIR instruments are qualified prior to usage and that documented evidence supports their performance reliability.

5. Procedure

5.1 Pre-Qualification Requirements

1. Ensure the FTIR instrument is installed and calibrated.
2. Use certified polystyrene film (e.g., 0.05 mm thickness) for performance checks.
3. Ensure the instrument’s environment is clean, with minimal vibration and temperature control between 20–25°C.

5.2 Wavenumber Accuracy Test

1. Place certified polystyrene film on the sample compartment.
2. Scan from 4000 cm^-1 to 600 cm^-1.
3. Verify absorption bands at 3060.0 cm^-1, 2849.5 cm^-1, 1942.9 cm^-1, 1601.2 cm^-1, 1583.0 cm^-1, 1154.5 cm^-1, and 1028.3 cm^-1.
4. Ensure band positions are within ±1.0 cm^-1 tolerance.

5.3 Resolution Test

1. Verify resolution at 1154.5 cm^-1 and 1028.3 cm^-1 peaks.
2. The minimum height ratio between the valley at ~1089 cm^-1 and the 1028 cm^-1 peak must be ≥18:1 (as per USP or manufacturer guidelines).

5.4 Reproducibility and Signal-to-Noise Ratio

1. Perform 10 scans using background spectrum.
2. Calculate noise in baseline region (2200–2000 cm^-1) and determine the signal-to-noise ratio.
3. S/N ratio should meet or exceed manufacturer’s specification (typically ≥30000:1).

5.5 Baseline Flatness and Stability

1. Scan empty sample compartment 10 times over 4000–600 cm^-1.
2. Record baseline stability and flatness; deviation should be ≤0.01 A over the scan range.

5.6 Data Compilation and Review

1. Record all results in Annexure-1: FTIR PQ Log.
2. Attach spectral graphs and software reports to the qualification binder.
3. Submit completed PQ document for QA review and approval.

6. Abbreviations

• FTIR: Fourier Transform Infrared Spectrophotometer
• PQ: Performance Qualification
• S/N: Signal-to-Noise
• A: Absorbance
• QA: Quality Assurance

7. Documents

1. Annexure-1: FTIR PQ Summary Log
2. Annexure-2: Certified Polystyrene Reference Sheet
3. Annexure-3: Baseline and S/N Evaluation Graphs

8. References

• USP <861>: Infrared Spectroscopy
• ICH Q2(R1): Validation of Analytical Procedures
• Instrument Manufacturer Manuals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ritika Sharma	Amit Joshi	Dr. Kavita Arora
Designation	Analyst	QA Officer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: FTIR PQ Summary Log

Date	Test Performed	Acceptance Criteria	Results	Status
01/06/2025	Wavenumber Accuracy	±1.0 cm-1	Pass	Pass
01/06/2025	Resolution	≥18:1 peak ratio	Pass	Pass

Annexure-2: Certified Polystyrene Reference Sheet

Certified data for standard peak positions for comparison and verification during qualification.

Annexure-3: Baseline and S/N Evaluation Graphs

Printouts of scan showing baseline flatness, signal-to-noise calculations, and spectral integrity signatures.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Updated with additional resolution and reproducibility parameters	Annual SOP update	Dr. Kavita Arora
15/07/2022	1.0	Initial Issue	New SOP Implementation	QA Head