in the Analytical Method Development (AMD) laboratory. System suitability tests (SST) confirm that the system is operating correctly before and during analytical runs to ensure method reliability and data integrity.

2. Scope

This procedure applies to all HPLC and GC methods being developed, validated, transferred, or used for routine quality control within the AMD function for raw materials, APIs, and finished products.

3. Responsibilities

• Analyst: Prepares system suitability standards, initiates runs, calculates system suitability parameters.
• AMD Scientist: Defines acceptance criteria based on method development studies and literature references.
• QA: Reviews system suitability trends and approves SST criteria during validation and transfer.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring compliance with SST protocols in accordance with ICH, USP, and regulatory guidelines.

5. Procedure

5.1 Identification of SST Parameters

Select system suitability parameters relevant to the method type and critical performance attributes:

• Retention Time (RT)
• Theoretical Plates (N)
• Resolution (Rs)
• Tailoring Factor (T)
• Repeatability (%RSD) of peak area from multiple injections

5.2 Preparation of SST Standard

1. Prepare standard solution at defined concentration according to the analytical method.
2. Filter and sonicate the solution if required.
3. Ensure that SST standard contains analyte and impurities where applicable.

5.3 Instrumental Setup and Injections

1. Use validated or qualified instruments (HPLC/GC) for all SST evaluations.
2. Inject 5–6 replicates of SST standard solution to evaluate repeatability and other criteria.
3. Ensure column equilibrium and consistent baseline before starting injections.

5.4 Acceptance Criteria

Parameter	Typical Acceptance Range
% RSD (Peak Area)	Not more than 2.0%
Resolution (Rs) between main peak and impurity	Not less than 2.0
Theoretical Plates (N)	As per method development; typically > 2000
Tailoring Factor	1.0–2.0

5.5 Troubleshooting

1. If SST criteria fail, do not analyze test samples.
2. Investigate root cause (e.g., column condition, mobile phase, injection volume, temperature).
3. Document any deviation and recondition the system or replace column if necessary.

5.6 Documentation

1. Record SST results in the System Suitability Record Sheet (Annexure-1).
2. Attach chromatograms of all injections used for SST calculation.
3. Include a justification section in validation or routine reports referring to SST results.

6. Abbreviations

• SST: System Suitability Test
• RT: Retention Time
• N: Theoretical Plates
• Rs: Resolution
• RSD: Relative Standard Deviation

7. Documents

1. Annexure-1: System Suitability Record Sheet
2. Annexure-2: SST Deviation Log
3. Instrument Logbook

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• USP General Chapter <621> Chromatography
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• Internal SOPs on HPLC/GC Qualification

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Anil Jha	Pooja Mahadik	Dr. Shravan Kumar
Designation	Senior Analyst	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: System Suitability Record Sheet

Injection No.	Peak Area	RT (min)	Resolution	Tailing Factor	Plates (N)
1	2501	5.65	2.5	1.15	3400
2	2503	5.64	2.6	1.14	3420
3	2498	5.63	2.5	1.13	3390

Annexure-2: SST Deviation Log

Date	Instrument ID	Deviation Observed	Action Taken	Remarks
31/05/2025	HPLC-007	RSD above 2.5%	Reconditioning of column	Criteria met post re-run

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Expanded procedure for troubleshooting and tabular criteria	Annual SOP Review	Dr. Shravan Kumar
05/06/2022	1.0	First Release	New SOP	QA Head