batches of sterile injectable finished products manufactured at the facility and tested by the Quality Control Laboratory prior to release.

3. Responsibilities

• QC Analyst: Performs the identity tests and records observations.
• QC Reviewer: Reviews results and calculations for correctness and compliance.
• QA Officer: Ensures documentation compliance and handles deviations, if any.

4. Accountability

The Head of Quality Control is accountable for the execution, review, and accuracy of identity testing activities.

5. Procedure

5.1 Sample Preparation

1. Receive the sample in the QC laboratory as per the Sample Receipt Log (Annexure-1).
2. Ensure that all test materials are clean, labeled, and within validity.
3. Prepare the sample according to the respective pharmacopeial monograph or validated method.

5.2 Selection of Identity Test Method

1. Follow the appropriate pharmacopeial method (USP, IP, BP, or Ph. Eur.) for the specific product/API.
2. Use chromatographic, spectrophotometric, or chemical identification methods based on the product specification.

5.3 Execution of the Identity Test

1. Run positive control (standard) and blank as per the method.
2. Inject or process the test sample and compare results with the standard.
3. Confirm retention time (for HPLC), peak match (UV/IR), or expected color change (chemical methods).
4. Document all observations and results in the Identity Test Report (Annexure-2).

5.4 Acceptance Criteria

1. Results must match the standard in all parameters specified by the method.
2. Deviation from expected results shall be handled as an Out-of-Specification (OOS) event.

5.5 Documentation

1. Record all test parameters, equipment ID, analyst initials, and time of test execution.
2. Attach chromatograms, spectra, or observations in the final report for batch release documentation.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• HPLC: High Performance Liquid Chromatography
• API: Active Pharmaceutical Ingredient
• OOS: Out of Specification

7. Documents

1. Sample Receipt Log – Annexure-1
2. Identity Test Report – Annexure-2
3. Instrument Usage Log – Annexure-3

8. References

• USP <191> Identification Tests – General Notices
• IP Monographs – Product Specific
• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Analyst	QA Executive	Head QA
Department	Quality Control	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Sample Receipt Log

Date	Product	Batch No.	Received By	Remarks
16/06/2025	Gentamicin Injection	GEN-0625-A	Sunita Reddy	For Identity Testing

Annexure-2: Identity Test Report

Product	Batch No.	Method Used	Result	Remarks
Gentamicin Injection	GEN-0625-A	HPLC USP Monograph	Complies	Meets Specification

Annexure-3: Instrument Usage Log

Date	Instrument ID	Used By	Purpose	Remarks
16/06/2025	HPLC-102	Rajesh Kumar	Identity Testing	Completed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
18/06/2025	2.0	Aligned with revised USP monograph	Regulatory Update	QA Head