applies to all personnel performing HPLC, UPLC, or GC-based chromatographic analyses in the Analytical Method Development (AMD) laboratory, where system suitability tests (SST) are mandatory to ensure analytical system performance.

3. Responsibilities

• Analyst: Executes system suitability runs and records parameters as per method SOP.
• AMD Scientist: Verifies acceptability of SST results and authorizes method execution.
• QA Reviewer: Audits documentation for completeness and ensures compliance with regulatory standards.

4. Accountability

The Head of AMD is accountable for implementation and control of this SOP, ensuring all chromatographic SST data are properly reviewed, documented, and retained.

5. Procedure

5.1 Understanding System Suitability Tests

1. System suitability tests are conducted to verify that the analytical system is adequate for performing the intended analysis.
2. Parameters assessed typically include:
   • Theoretical plates (N)
   • Tailing factor (T)
   • Resolution (Rs)
   • Repeatability (%RSD of peak area or retention time)
3. Acceptance criteria must be predefined in the method SOP based on validation studies or pharmacopeial recommendations.

5.2 Preparation for Chromatographic Runs

1. Ensure the system (e.g., HPLC/UPLC/GC) is calibrated and qualified.
2. Use freshly prepared mobile phase and equilibrate the system as per method conditions.
3. Inject standard solution as defined and allow system stabilization if required.

5.3 Recording System Suitability Parameters

1. After successful injection of standards:
   • Extract chromatograms and system-generated parameters from the software.
   • Record the following manually or via electronic data:
     • Retention time (Rt)
     • Peak area
     • Tailing factor
     • Theoretical plates
     • Resolution between critical peaks
     • Baseline noise (if applicable)
2. Enter these parameters into the System Suitability Log Sheet (Annexure-1).

5.4 Evaluation of System Suitability

1. Compare recorded SST values against the method-specific acceptance criteria.
2. If any parameter fails to meet criteria:
   • Do not proceed with sample injections.
   • Notify AMD Scientist and initiate investigation as per SOP for OOS/OOT handling.
3. If parameters pass:
   • Document ‘System suitability criteria met’ on analytical worksheet.
   • Proceed with analysis of test samples.

5.5 Data Integrity and Audit Trail

1. All chromatographic data must be stored securely within validated CDS software.
2. Ensure audit trail captures all modifications and re-integrations.
3. Printouts or electronic records should include chromatograms and summary reports with SST values.

5.6 Review and Approval

1. AMD Scientist to review and sign off on SST data and analytical worksheet before submission to QA.
2. QA to verify SST documentation as part of batch release or validation packet review.

6. Abbreviations

• SST: System Suitability Test
• HPLC: High-Performance Liquid Chromatography
• GC: Gas Chromatography
• UPLC: Ultra Performance Liquid Chromatography
• RSD: Relative Standard Deviation

7. Documents

1. System Suitability Log Sheet – Annexure-1
2. Chromatographic Data Review Checklist – Annexure-2
3. Instrument Audit Trail Verification Log – Annexure-3

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• 21 CFR Part 211 – Current Good Manufacturing Practices
• USP General Chapter <621> – Chromatography

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ankita Sharma	Dr. Ravi Chandra	Dr. Harshita Goyal
Designation	Analyst	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: System Suitability Log Sheet

Template to record retention time, theoretical plates, resolution, tailing factor, and RSD for standard injections.

Annexure-2: Chromatographic Data Review Checklist

Checklist includes items such as proper labeling, complete chromatograms, SST values, injection sequence, and calibration curve verification.

Annexure-3: Instrument Audit Trail Verification Log

Record audit trail checks performed before and after analysis, including reviewer name, date, observations, and comments.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Updated for audit trail and integrity checks	Annual SOP review	Dr. Harshita Goyal
10/08/2022	1.0	Initial release	New SOP	QA Head