applicable to all chromatographic (HPLC, GC, UPLC) and instrumental analytical methods used in the Analytical Method Development (AMD) department.

3. Responsibilities

• Analyst: Performs and documents system suitability evaluations prior to sample injection.
• AMD Documentation Officer: Maintains and verifies logs and result sheets for each system suitability test.
• QA Reviewer: Reviews compliance with pre-defined criteria and initiates deviation reports if necessary.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that system suitability evaluations are conducted, recorded, and reviewed for every analytical run.

5. Procedure

5.1 General Guidelines

1. Perform system suitability prior to each sample sequence or analytical batch.
2. Use a freshly prepared system suitability solution or standard solution.
3. Ensure that all system settings (temperature, flow rate, injection volume) are in accordance with method parameters.

5.2 System Suitability Parameters

Typical parameters include but are not limited to:

• Retention Time (RT)
• Resolution (Rs)
• Theoretical Plates (N)
• Tailing Factor (T)
• Repeatability (%RSD for peak area or height)

5.3 Acceptance Criteria

1. Refer to the validated method or protocol for specific parameter thresholds.
2. For example:
   • Resolution between critical pair: ≥ 2.0
   • Tailing Factor: ≤ 2.0
   • Repeatability: %RSD ≤ 2.0 for replicate injections
   • Theoretical Plates: As per method validation report

5.4 Execution Steps

1. Prepare system suitability solution as per method.
2. Inject 5–6 replicates and record results.
3. Use instrument software to calculate suitability metrics.
4. Document all readings in System Suitability Log (Annexure-1).

5.5 Actions on Failure

1. If parameters do not meet acceptance criteria:
   • Stop sample injections.
   • Check mobile phase preparation, column condition, detector baseline.
   • Perform necessary corrective actions (e.g., column flushing, flow rate adjustment).
   • Repeat system suitability check after adjustments.

5.6 Documentation

1. Record all suitability results in Annexure-1.
2. Attach printouts or screenshots from instrument software.
3. Deviations must be logged using Deviation Report Format (Annexure-2).

6. Abbreviations

• RT: Retention Time
• Rs: Resolution
• N: Theoretical Plates
• RSD: Relative Standard Deviation

7. Documents

1. Annexure-1: System Suitability Evaluation Log
2. Annexure-2: Deviation Report Format

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• USP <621> – Chromatography
• FDA Guidance on Chromatographic Data Integrity

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ravi Sharma	Sapna Desai	Dr. Ishaan Mehta
Designation	AMD Analyst	QA Reviewer	Head – Analytical Method Development
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: System Suitability Evaluation Log

Date	Instrument ID	Method	RT	Rs	Tailing	%RSD	Status
01/06/2025	HPLC-102	ASSAY-001	5.6	2.3	1.2	1.1	Pass

Annexure-2: Deviation Report Format

Deviation ID	Date	Description	Root Cause	Corrective Action	Status
DEV-353-01	01/06/2025	High tailing factor	Column aging	Column replacement	Closed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Included enhanced evaluation parameters and deviation handling	Annual SOP Review	Dr. Ishaan Mehta
01/06/2022	1.0	Initial release	New SOP	QA Head