approve or reject materials based on test results. The Warehouse Manager ensures proper handling and segregation of materials awaiting verification.

5. Procedure

5.1 Pre-Analysis Preparations

1. Instrument Calibration:
   • Ensure FTIR and Raman spectrometers are calibrated as per manufacturer’s guidelines.
   • Document calibration details in the Instrument Calibration Log (Annexure-1).
2. Sample Preparation:
   • Collect samples from the designated quarantine area following standard sampling procedures.
   • Prepare samples in accordance with the specific requirements of FTIR or Raman analysis (e.g., pellet formation for FTIR, vial preparation for Raman).

5.2 Performing FTIR/Raman Analysis

1. FTIR Analysis Procedure:
   • Place the sample in the sample holder or form a pellet using KBr (if applicable).
   • Run the FTIR scan from 4000 to 400 cm^-1.
   • Compare the obtained spectrum with the reference spectrum in the database.
   • Document the analysis results in the FTIR Analysis Log (Annexure-2).
2. Raman Analysis Procedure:
   • Place the sample in the Raman spectrometer.
   • Select appropriate laser settings (e.g., 785 nm or 532 nm) based on the material’s characteristics.
   • Run the Raman scan and compare the spectrum to the reference library.
   • Document the analysis results in the Raman Analysis Log (Annexure-3).

5.3 Data Interpretation and Verification

1. Comparison with Reference Standards:
   • Compare the sample spectra to the reference spectra to ensure a match within the acceptable spectral correlation limits (typically ≥ 90%).
   • Record any deviations or inconsistencies.
2. Documentation of Results:
   • Complete the Identity Verification Report (Annexure-4) for each material tested.
   • Submit the report to QA for review and final approval.

5.4 Approval and Material Disposition

1. QA Review and Approval:
   • QA reviews the FTIR/Raman test results and compares them with the material specifications.
   • Approve materials that meet the identity verification criteria, moving them to the approved storage area.
   • Reject materials with discrepancies and move them to the rejection area. Document disposition in the Material Disposition Log (Annexure-5).

5.5 Handling Non-Conforming Results

1. Identification of Non-Conforming Materials:
   • Document non-conforming results in the Non-Conformance Report (Annexure-6).
   • Quarantine non-conforming materials and notify Procurement and QA for further investigation.
2. Corrective Actions:
   • Procurement contacts the supplier for clarification or replacement.
   • QA initiates an investigation into the root cause of the discrepancy.

6. Abbreviations

• SOP: Standard Operating Procedure
• FTIR: Fourier Transform Infrared Spectroscopy
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• KBr: Potassium Bromide

7. Documents

1. Instrument Calibration Log (Annexure-1)
2. FTIR Analysis Log (Annexure-2)
3. Raman Analysis Log (Annexure-3)
4. Identity Verification Report (Annexure-4)
5. Material Disposition Log (Annexure-5)
6. Non-Conformance Report (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q2(R1) – Validation of Analytical Procedures
• USP <941> – Identity Tests—Infrared Spectroscopy

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Instrument Calibration Log

Date	Instrument	Calibration Standard Used	Calibration Result	Calibrated By	Remarks
01/02/2025	FTIR Spectrometer	Polystyrene Film	Pass	John Doe	Instrument Ready for Use
01/02/2025	Raman Spectrometer	Silicon Wafer	Pass	Jane Smith	Instrument Calibrated

Annexure-2: FTIR Analysis Log

Date	Material Name	Batch Number	Sample ID	Spectral Match (%)	Result	Analyzed By
02/02/2025	API-X	X-2025-001	SAMP-001	98%	Pass	Mark Lee
02/02/2025	Excipient-Y	Y-2025-002	SAMP-002	85%	Fail	Anna White

Annexure-3: Raman Analysis Log

Date	Material Name	Batch Number	Sample ID	Spectral Match (%)	Result	Analyzed By
02/02/2025	API-Z	Z-2025-003	SAMP-003	95%	Pass	John Doe

Annexure-4: Identity Verification Report

Date	Material Name	Batch Number	Test Method	Result	QA Review	Remarks
03/02/2025	API-X	X-2025-001	FTIR	Pass	Approved	Material Meets Specifications
03/02/2025	Excipient-Y	Y-2025-002	FTIR	Fail	Rejected	Spectral Match Below Threshold

Annexure-5: Material Disposition Log

Date	Material Name	Batch Number	Disposition	Approved By	Remarks
04/02/2025	API-X	X-2025-001	Approved	QA Manager	Meets Specifications
04/02/2025	Excipient-Y	Y-2025-002	Rejected	QA Manager	Failed Identity Verification

Annexure-6: Non-Conformance Report

Date	Material Name	Batch Number	Non-Conformance Description	Corrective Action	Status
03/02/2025	Excipient-Y	Y-2025-002	Failed FTIR Identity Test	Supplier Notified, Material Returned	Closed

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Added Raman Spectroscopy Procedure	Standardization	QA Head