run integrity, identifies failures, documents observations, and proposes corrective actions.

Lab Supervisor: Reviews reasons for failure, approves reanalysis plans, and ensures proper documentation.

QA: Audits failed run records and ensures CAPA implementation where required.

4. Accountability

The Bioanalytical Laboratory Head is accountable for ensuring failed or partial runs are handled per regulatory expectations and are appropriately justified and recorded.

5. Procedure

5.1 Definitions

• Partial Run: A run in which only part of the sequence was completed or part of the data is unusable due to instrument, sample, or operational issues.
• Failed Run: A run where the calibration curve fails to meet acceptance criteria, invalidating the entire batch.

5.2 Identification of a Partial or Failed Run

1. Monitor every run for:
   • Calibration curve linearity and back-calculated concentrations.
   • System Suitability Test (SST) results.
   • Internal standard response consistency.
   • Chromatographic anomalies (e.g., split peaks, baseline drift).
2. If any of the above fail, classify the run as partial or failed and halt further injections.

5.3 Documentation

1. Document failed/partial run in Annexure-1: Run Failure Record.
2. Include chromatograms, SST, calibration data, and reasons for run failure.
3. Flag all data as “Do Not Use” in raw data folder and label with a red tag.

5.4 Root Cause Investigation

1. Investigate the issue under supervision:
   • Instrument malfunction: Check logs, gas supply, pressure, pump performance.
   • Sample preparation error: Re-extract QC and study samples.
   • Software/data acquisition error: Report and validate sequence file settings.
2. Record the investigation in Annexure-2: Run Investigation Log.

5.5 Approval for Reanalysis

1. Submit justification for reanalysis to Lab Supervisor and QA.
2. Approval to repeat analysis must be documented and attached to raw data package.

5.6 Reprocessing vs Reanalysis

1. Reprocessing: Acceptable if raw data (chromatograms) is intact and original integration was erroneous.
2. Reanalysis: Required if:
   • Sample vials were not injected.
   • System issues impacted ionization.
   • Inappropriate results due to matrix effects, degradation, etc.
3. All reanalysis activities must be documented in Annexure-3: Reanalysis Approval Form.

5.7 Data Archival and Final Reporting

1. Clearly segregate valid and invalid runs in the final report and assign separate identifiers (e.g., RUN-01F for failed).
2. Attach failure justification, corrected data, and impact analysis in the final bioanalytical report.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• SST: System Suitability Test
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance

7. Documents

1. Run Failure Record – Annexure-1
2. Run Investigation Log – Annexure-2
3. Reanalysis Approval Form – Annexure-3

8. References

• ICH M10: Bioanalytical Method Validation
• FDA Bioanalytical Method Validation Guidance
• Internal Quality System Manual

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Run Failure Record

Run ID	Date	Reason for Failure	Initiated By	Reviewed By
RUN-102	15/04/2025	Curve R² < 0.98	Sunita Reddy	QA Officer

Annexure-2: Run Investigation Log

Run ID	Observation	Investigation Summary	Corrective Action
RUN-102	Low peak area for all QCs	Column pressure dropped	Column replaced

Annexure-3: Reanalysis Approval Form

Date	Sample IDs for Reanalysis	Reason	Approved By
16/04/2025	BE001-TP3, BE001-TP5	Pump failure during injection	Lab Supervisor

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial issue	New SOP	QA Head
17/04/2025	2.0	Added definitions and reprocessing policy	Regulatory update	QA Head