further processing or release.

4. Accountability

The QC Manager is accountable for ensuring that FTIR analysis is conducted in accordance with this SOP. The Production Supervisor is responsible for providing accurate and representative samples for testing. The QA Manager ensures that the results are reviewed and approved in compliance with GMP and regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the FTIR spectrometer is calibrated according to the manufacturer’s instructions to ensure accurate readings.
2. Ensure that the necessary sample preparation tools and solvents (e.g., potassium bromide, ethanol) are available and ready for use.
3. Review the batch record to determine the specific ingredients and cream samples to be tested and to confirm the test specifications.

5.2 Sample Collection

1. Collect representative samples of the cream ingredients and finished product formulations. The samples should be homogenous and free from contamination.
2. Label each sample with the batch number, sample ID, sampling date, and the ingredients used in the formulation to ensure traceability during testing.
3. Ensure that the samples are collected from properly prepared and finalized formulations, ready for testing.

5.3 FTIR Analysis Procedure

1. Prepare the sample for FTIR analysis by placing a small amount of the sample (e.g., 1-2 mg) onto a potassium bromide (KBr) pellet or directly on the FTIR sample plate.
2. Place the prepared sample into the FTIR spectrometer. Ensure that the sample is positioned correctly to obtain a clean reading.
3. Run the FTIR scan within the designated range (typically 4000–400 cm⁻¹) to obtain the infrared absorption spectrum of the sample.
4. Perform the scan according to the instrument’s specifications. Ensure that each sample is scanned at least three times for consistency.
5. Record the FTIR spectrum generated by the instrument for analysis. Compare the observed peaks with known reference spectra for each ingredient to confirm the chemical composition of the sample.

5.4 Interpretation of Results

1. Compare the FTIR spectrum of the sample with reference spectra from recognized sources (e.g., ingredient suppliers, published libraries) to confirm the identity and purity of the active ingredients and excipients.
2. Verify that the spectrum matches the expected profile for the ingredient. If the spectrum differs significantly, mark the test as “Fail” and investigate the cause of the discrepancy.
3. If the FTIR spectrum confirms the expected identity, mark the test as “Pass” in the FTIR Test Log (Annexure-1) and proceed with the next stage of production or release.

5.5 Post-Test Activities

1. Record all test results, including batch number, sample ID, FTIR spectrum, and any discrepancies or deviations observed, in the FTIR Test Log (Annexure-1).
2. If the FTIR analysis fails, initiate corrective actions, such as reviewing the raw material batch, checking supplier certificates of analysis, or re-testing the sample with different preparation methods.
3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

5.6 Documentation and Record-Keeping

1. Ensure that all FTIR testing records are complete, accurate, and securely stored. This includes the FTIR Test Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• FTIR: Fourier Transform Infrared

7. Documents

1. Annexure-1: FTIR Test Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Pharmacopeial Monographs for FTIR Testing

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 Test Log

Batch Number	Sample ID	Test Date	FTIR Spectrum	Operator
12345	S-001	21/01/2026	Pass (Spectra matched with reference)	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Discrepancy in FTIR spectrum	Re-tested with new sample preparation	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head