data before and during analytical runs.

2. Scope

This SOP applies to all analytical methods developed, validated, or transferred in the Analytical Method Development laboratory, including HPLC, GC, UV-Vis, and other instrumental techniques used for quality testing of APIs and drug products.

3. Responsibilities

• Analytical Scientist: Develops and documents the system suitability parameters and performs initial runs.
• Group Leader: Reviews the system suitability performance during method development and validation stages.
• QA Executive: Verifies established parameters against regulatory standards and approves final criteria.
• Department Head: Ensures compliance and implementation of system suitability requirements.

4. Accountability

The Head of Analytical Method Development is accountable for the proper establishment, review, and implementation of system suitability criteria across all validated and development methods.

5. Procedure

5.1 Understanding System Suitability

1. System suitability testing is performed to verify that the analytical system is adequate for the intended analysis.
2. Common parameters include:
   • Retention time (RT)
   • Resolution (Rs)
   • Theoretical plates (N)
   • Tailing factor (T)
   • Relative standard deviation (RSD%)
   • Signal-to-noise ratio (S/N) for low-level methods

5.2 Designing Suitability Criteria

1. Based on method purpose, define criteria using standard or spiked solutions:
   • Resolution between critical pairs ≥ 2.0
   • Theoretical plates ≥ 2000 (HPLC/GC)
   • Tailing factor ≤ 2.0
   • % RSD for replicate injections ≤ 2.0%
2. Calculate parameters from three to six replicate injections using suitable software or manually as needed.

5.3 Validation of Suitability Parameters

1. Evaluate system suitability during:
   • Method development
   • Method validation
   • System calibration or performance qualification
2. Establish criteria in Annexure-1 and validate it across multiple runs and days.

5.4 Application of Suitability Criteria

1. Before every batch analysis or validation run:
   • Inject standard solution or system suitability mix
   • Compare obtained values against pre-defined limits
   • If parameters fail, stop the analysis and troubleshoot
2. Document in Annexure-2: Suitability Monitoring Log.

5.5 Troubleshooting

1. If system suitability fails, investigate:
   • Column performance degradation
   • Improper mobile phase preparation
   • Detector lamp deterioration
   • System leaks or blockages
2. Document deviations and corrective actions in Annexure-3.

6. Abbreviations

• SOP: Standard Operating Procedure
• RT: Retention Time
• Rs: Resolution
• N: Theoretical Plates
• RSD: Relative Standard Deviation
• QA: Quality Assurance

7. Documents

1. System Suitability Criteria Log – Annexure-1
2. System Suitability Monitoring Log – Annexure-2
3. Deviation and Corrective Action Report – Annexure-3

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• USP <621>: Chromatography
• WHO TRS 996: Quality Assurance of Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Aditi Joshi	Manoj Pillai	Sunita Reddy
Designation	Analyst	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: System Suitability Criteria Log

Parameter	Target	Acceptance Range	Basis
Resolution (Rs)	2.5	≥ 2.0	Critical pair
Theoretical Plates (N)	3000	≥ 2000	Main peak
Tailing Factor	1.1	≤ 2.0	Main peak
% RSD	0.5%	≤ 2.0%	6 replicate injections

Annexure-2: System Suitability Monitoring Log

Date	Analyst	Method Name	RSD%	Resolution	Status
20/05/2025	Aditi Joshi	Assay of Diclofenac	0.6%	2.3	Pass

Annexure-3: Deviation and Corrective Action Report

Date	Deviation Description	Root Cause	Corrective Action	Reviewed By
15/05/2025	RSD > 2%	Mobile phase not equilibrated	Recondition column, re-prepare mobile phase	QA – Manoj Pillai

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Added troubleshooting and acceptance rationale	Annual Review	Sunita Reddy
10/04/2022	1.0	Initial Release	New SOP	QA Head