in API manufacturing.

3. Responsibilities

• QC Analyst: Operate the FTIR spectrometer as per this SOP and record observations accurately.
• QC Reviewer: Review and approve the FTIR results and ensure compliance with specification and method.
• Instrument Coordinator: Ensure calibration, maintenance, and troubleshooting of FTIR spectrometer.

4. Accountability

The Quality Control Head is accountable for ensuring compliance with the SOP and maintaining FTIR system readiness for routine and validation analysis.

5. Procedure

5.1 Instrument Setup

1. Switch on the main power supply and instrument PC.
2. Launch the FTIR software (e.g., OMNIC, Spectrum, etc.).
3. Allow the instrument to stabilize for a minimum of 30 minutes.
4. Check the instrument logbook for any ongoing maintenance or deviations.

5.2 Background Scan

1. Ensure the sample compartment is empty and clean.
2. Select “Collect Background” from the software.
3. Use a suitable number of scans (e.g., 32) and appropriate resolution (e.g., 4 cm⁻¹).
4. Save the background file with date and analyst initials.

5.3 Sample Preparation

1. Prepare sample based on material type:
   • Solid samples: Prepare KBr pellets or use ATR (Attenuated Total Reflectance) technique.
   • Liquid samples: Use appropriate liquid cells or ATR with a clean crystal.
2. Ensure that the reference standard is similarly prepared for comparison.
3. Clean the sampling accessories before and after use.

5.4 Spectrum Collection

1. Place the sample on the ATR crystal or in the sample holder.
2. Click “Collect Sample” in the software and run at least 32 scans.
3. Ensure a proper signal-to-noise ratio and well-defined peaks.
4. Compare with standard spectrum and overlay both for confirmation.

5.5 Interpretation and Reporting

1. Assign functional group peaks (e.g., O-H, N-H, C=O, C-H, etc.) according to literature.
2. Print spectrum and attach to worksheet along with:
   • Sample name, batch number
   • Reference used
   • Analyst name, date
3. Document results in the FTIR Analysis Log (Annexure-1).

5.6 Calibration and Verification

1. Perform wavelength accuracy check using polystyrene film once per week or before use.
2. Record calibration in the FTIR Calibration Log (Annexure-2).
3. Ensure absorbance accuracy and repeatability are verified monthly.

5.7 Maintenance and Cleaning

1. Clean the sample area daily using lint-free tissue and ethanol.
2. Close software and shut down instrument properly after use.
3. Log maintenance in the Instrument Maintenance Record (Annexure-3).

6. Abbreviations

• FTIR: Fourier Transform Infrared
• QC: Quality Control
• KBr: Potassium Bromide
• ATR: Attenuated Total Reflectance
• SOP: Standard Operating Procedure

7. Documents

1. FTIR Analysis Log (Annexure-1)
2. FTIR Calibration Log (Annexure-2)
3. Instrument Maintenance Record (Annexure-3)
4. Spectra Printouts and Interpretation Sheets

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• Instrument Manufacturer Manual
• 21 CFR Part 211 (cGMP for Analytical Equipment)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: FTIR Analysis Log

Date	Sample ID	Reference	Instrument ID	Analyst	Result
13/04/2025	SMP-148	API-STD-001	FTIR-01	Sunita Reddy	Complies

Annexure-2: FTIR Calibration Log

Date	Calibration Performed	Polystyrene Film Used	Wavelength Accuracy	Performed By
10/04/2025	Yes	PS-2025	Within 1 cm⁻¹	Ravi Kumar

Annexure-3: Instrument Maintenance Record

Date	Activity	Performed By	Remarks
13/04/2025	Cleaned ATR Crystal	Rajesh Kumar	No residue observed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial issue	Instrument Operation SOP	QA Head
13/04/2025	2.0	Format standardization and annexure addition	Internal Audit Requirement	QA Head