at the bioanalytical laboratory.

3. Responsibilities

• Analyst: Performs initial batch review and flags issues requiring batch rejection.
• QA Officer: Reviews justification for rejection and ensures documentation is complete.
• Bioanalytical Reviewer: Approves repeat analysis plan and verifies data compliance post-repeat.
• Bioanalytical Head: Authorizes final decision on batch rejection and approves repeat analysis.

4. Accountability

The Bioanalytical Head is accountable for maintaining data integrity by ensuring rejected batches are properly documented and repeat analyses are justified and conducted according to applicable guidelines.

5. Procedure

5.1 Criteria for Batch Rejection

1. An analytical batch shall be rejected if:
   • QC sample failure exceeds the acceptable limits as per ICH M10 (more than 33% of total or 50% at any level).
   • Calibration curve fails to meet accuracy or linearity criteria.
   • System suitability parameters (e.g., peak shape, retention time) are out of range.
   • Chromatographic issues such as interference, co-elution, or carryover.
   • Deviation in run sequence, labeling, or sample position errors.

5.2 Documentation of Batch Rejection

1. Record rejection details in Annexure-1: Batch Rejection Log including:
   • Run ID
   • Study code
   • Date of analysis
   • Reason for rejection
   • Authorized by
2. Annotate chromatograms and data files clearly with “REJECTED” watermark and maintain in the archival file.

5.3 Planning Repeat Analysis

1. Prepare a Repeat Analysis Request Form (Annexure-2) with:
   • List of samples to be repeated
   • Justification
   • Proposed method and timeline
2. QA and Bioanalytical Head must jointly approve the repeat analysis plan before initiation.
3. Repeat analysis must use:
   • Fresh calibration and QC samples
   • Same method and validated parameters

5.4 Conduct of Repeat Analysis

1. Follow same procedures as in the original batch preparation and processing.
2. Maintain records in the Repeat Analysis Log (Annexure-3).
3. Tag repeat runs with a unique batch ID and reference original run ID.

5.5 Review and Reporting

1. Compare original and repeat results and justify any variation in values exceeding ±20%.
2. Include repeat run data in the bioanalytical report with annotations and explanation for original run failure.
3. Ensure that the final reported result is from the repeat batch unless otherwise justified.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• ICH: International Council for Harmonisation

7. Documents

1. Batch Rejection Log – Annexure-1
2. Repeat Analysis Request Form – Annexure-2
3. Repeat Analysis Log – Annexure-3

8. References

• ICH M10 Bioanalytical Method Validation Guideline
• FDA Guidance on Bioanalytical Method Validation (2022)
• OECD GLP Principles

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Rejection Log

Date	Run ID	Study Code	Reason	Approved By
17/04/2025	RUN-058	BE/ABC/2025	QC Failure	Sunita Reddy

Annexure-2: Repeat Analysis Request Form

Sample IDs	Original Run ID	Justification	Approval Date	Authorized By
SUB005, SUB006	RUN-058	Peak anomaly	17/04/2025	Rajesh Kumar

Annexure-3: Repeat Analysis Log

Date	Repeat Run ID	Original Run ID	Analyst	Remarks
18/04/2025	RUN-058R	RUN-058	Ajay Verma	QC Passed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP	New Process Implementation	QA Head
17/04/2025	2.0	Included CAPA tracking and reinjection references	Audit Compliance	QA Head