GC, UPLC) used in analytical method development meets defined criteria before or during analysis.

2. Scope

This SOP applies to all chromatographic methods developed, validated, or transferred within the Analytical Method Development (AMD) department, including those used for product characterization, impurities profiling, and routine analytical tasks.

3. Responsibilities

• Analyst: Perform SST before sample analysis and document results.
• Reviewer (QA or Supervisor): Verify SST compliance and ensure proper documentation.
• AMD Head: Approve SST protocols and evaluate repeat SST failures.

4. Accountability

The AMD Head shall be accountable for ensuring that only systems that meet system suitability criteria are used for analytical testing and that failures are investigated promptly.

5. Procedure

5.1 General Requirements

1. System suitability must be evaluated before analyzing test samples.
2. Use the same column, system, and method parameters as mentioned in the analytical procedure.
3. Record SST results in the system suitability log (Annexure-1) and attach to raw data packet.

5.2 System Suitability Parameters

Parameters typically evaluated include:

• Retention time (tR): Consistency of analyte elution
• Resolution (Rs): Minimum between two closely eluting peaks
• Theoretical plates (N): Column efficiency
• Tailing factor (T): Peak symmetry (should be between 0.9–2.0)
• Relative standard deviation (RSD): Peak area or retention time reproducibility from replicate injections

5.3 SST Preparation

1. Prepare fresh mobile phase, system suitability solution, and column as specified.
2. Condition the system for at least 30 minutes before injecting SST solution.
3. Inject minimum five replicates of SST solution to determine system parameters.

5.4 Evaluation Criteria

Acceptable limits may vary depending on the method, but as general guidelines:

• RSD: ≤2.0% for peak area or retention time
• Resolution: ≥2.0 between critical pairs
• Tailing Factor: ≤2.0 for principal peaks
• Theoretical Plates: ≥2000 for analytical peaks

5.5 Handling SST Failures

1. Do not proceed with analysis if SST fails.
2. Document failure and perform investigation using a checklist (Annexure-2).
3. Check for mobile phase composition errors, column deterioration, instrument malfunction, or operator error.
4. If cause is confirmed and corrected, repeat SST.
5. Recurring SST failures must be escalated to AMD Head for CAPA initiation.

5.6 Documentation

1. Record all SST values, chromatograms, and calculations in the system suitability record form (Annexure-1).
2. Sign and date all entries.
3. Review and verify SST results before proceeding with test samples.

6. Abbreviations

• HPLC: High Performance Liquid Chromatography
• GC: Gas Chromatography
• SST: System Suitability Test
• RSD: Relative Standard Deviation
• CAPA: Corrective and Preventive Action

7. Documents

1. Annexure-1: System Suitability Log Template
2. Annexure-2: SST Failure Investigation Checklist

8. References

• USP <621> Chromatography
• ICH Q2(R1) – Validation of Analytical Procedures
• FDA Guidance for Industry – Chromatographic Methods

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Manoj Tiwari	Sunita Rao	Dr. Anurag Singh
Designation	Analyst	QA Officer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: System Suitability Log Template

Date	Method	Injection	RSD (%)	Resolution	Tailing	Theoretical Plates	Status
01/06/2025	Ibuprofen Assay	5	1.2	2.5	1.1	3800	Pass

Annexure-2: SST Failure Investigation Checklist

• Was mobile phase prepared correctly?
• Is column within qualification life?
• Is instrument showing any error?
• Was system adequately equilibrated?
• Any sample preparation issues?

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Included UPLC, SST failure flowchart, and updated annexures	Annual SOP revision	Dr. Anurag Singh
10/05/2022	1.0	Initial Release	New SOP	QA Head