or expectations.

3. Responsibilities

• QC Analyst: Notify supervisor of failed result and complete documentation accurately.
• QC Supervisor: Evaluate initial data and determine if reanalysis is scientifically justified.
• QA Officer: Approve reanalysis plan and review the final outcome and conclusions.

4. Accountability

The Quality Head is accountable for ensuring that reanalysis is not misused to discard legitimate OOS results and is only conducted when scientifically justified and properly documented.

5. Procedure

5.1 Identification of Failed Result

1. Any test result not meeting specification shall be reported immediately to the QC Supervisor.
2. Do not discard any test data, raw printouts, or sample preparations.
3. Label the sample “UNDER INVESTIGATION.”
4. Document the result in the QC worksheet and OOS Logbook (Annexure-1).

5.2 Preliminary Review

1. QC Supervisor shall:
   • Review calculations, instrument logs, chromatograms, and observations
   • Check system suitability and reference standard integrity
   • Confirm sample handling and preparation steps
2. If no apparent error is found, escalate to QA to initiate a formal OOS investigation.

5.3 Reanalysis Criteria

1. Reanalysis may be justified under these conditions:
   • Instrumental error (power failure, malfunction, calibration drift)
   • Obvious analyst error or contamination during preparation
   • Degradation or precipitation during sample storage
   • Use of incorrect STP or expired reagent
2. QA must approve the justification for reanalysis and assign a reanalysis plan using Annexure-2.

5.4 Conducting the Reanalysis

1. Use a fresh aliquot of the same sample where possible. If not, use a new sample from retained stock.
2. Prepare reagents, standards, and sample solution freshly as per the applicable STP.
3. Perform complete analysis, not just the failed parameter, if required by QA.
4. Ensure all new data is traceable and stored separately from the initial test.

5.5 Evaluation and Decision

1. If the reanalysis result conforms:
   • Investigate root cause of the original failure.
   • Determine if a laboratory error is confirmed.
2. If both initial and reanalysis results are out of specification:
   • Batch must be considered OOS.
   • Refer to QA for further action including deviation, CAPA, or rejection.
3. Summarize findings and rationale in the Reanalysis Report (Annexure-3).

5.6 Documentation

1. Record the following:
   • Original result and analyst’s observation
   • Root cause investigation outcome
   • QA approval for reanalysis
   • Reanalysis method and results
   • Final disposition recommendation
2. Retain all original and repeat results with time/date stamp and analyst initials.

6. Abbreviations

• OOS: Out of Specification
• OOT: Out of Trend
• QC: Quality Control
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• STP: Standard Test Procedure

7. Documents

1. OOS Logbook (Annexure-1)
2. Reanalysis Authorization Form (Annexure-2)
3. Reanalysis Report (Annexure-3)
4. QC Worksheets and Raw Data

8. References

• US FDA Guidance on Investigating OOS Test Results (2006)
• ICH Q7 – GMP for APIs
• 21 CFR Part 211.192

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: OOS Logbook

Date	Sample ID	Test	Result	Status	Remarks
13/04/2025	SMP-146	Assay	94.2%	OOS	Reanalysis Approved

Annexure-2: Reanalysis Authorization Form

Sample ID	Justification	Authorized By	Date
SMP-146	Suspected glassware contamination	QA Officer	13/04/2025

Annexure-3: Reanalysis Report

Test	Initial Result	Reanalysis Result	Disposition	Conclusion
Assay	94.2%	99.1%	Acceptable	Lab Error Confirmed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	Regulatory Compliance	QA Head
13/04/2025	2.0	Included Annexure Templates	Audit Feedback	QA Head