Practices (cGMP) and data integrity principles.

2. Scope

This SOP applies to all QC laboratory personnel involved in chemical, instrumental, and microbiological analysis of raw materials, in-process samples, finished products, and stability samples where test results are out-of-specification (OOS), out-of-trend (OOT), or require re-verification under specific conditions.

3. Responsibilities

• QC Analyst: Conducts the initial and repeat tests, records all observations, and notifies any OOS/OOT findings.
• QC Supervisor: Reviews investigation reports, assesses justification, and authorizes retesting if scientifically warranted.
• QA Executive: Ensures compliance with SOP and verifies that the repeat testing procedure was correctly followed.
• Head QC: Provides final approval for repeat testing and oversees completion of investigation and documentation.

4. Accountability

The Head of Quality Control is accountable for ensuring compliance with this SOP and regulatory requirements for data integrity and repeat testing.

5. Procedure

5.1 Initial Assessment

1. When test results fall outside of the specification or trend, the QC Analyst must immediately notify the Supervisor and QA.
2. Initiate an Out-of-Specification (OOS) or Out-of-Trend (OOT) investigation report using Annexure-1.
3. Conduct a preliminary laboratory investigation to check for analytical errors including:
• Sample preparation error
• Calculation mistakes
• Instrument malfunction
• Environmental influences

5.2 Conditions for Repeat Testing

Repeat testing shall be permitted only under the following conditions:

• Confirmed analyst error in sample preparation or dilution
• Malfunction of instrument or software (with evidence)
• Sample contamination or spillage
• Power failure or interruption during run
• Results invalidated due to lab condition deviations

Repeat testing must not be used to “average out” or disregard a valid failing result unless justified with investigation and QA approval.

5.3 Approval Process for Repeat Testing

1. Fill out the Repeat Testing Request Form (Annexure-2).
2. Attach investigation summary with evidence and proposed corrective action.
3. Get approval from:
   • QC Supervisor
   • QA Executive
   • Head of QC (final)
4. Only after written authorization can repeat testing be conducted.

5.4 Conducting Repeat Test

1. Repeat test must follow the original method under validated conditions.
2. Use the same batch/sample or retain if available. If not, a fresh sample can be drawn with justification.
3. All chromatograms, graphs, printouts, and raw data must be attached to the Repeat Test Report (Annexure-3).

5.5 Documentation and Interpretation

• All results, including initial and repeat tests, must be reported transparently.
• Final decision must be based on investigation outcome, not solely on passing repeat test results.
• QA shall review the repeat test data and record conclusions in the Investigation Closure Form (Annexure-4).

5.6 Reporting and Archiving

1. All completed documents shall be filed in the batch folder.
2. Scan and back up repeat testing reports on QC document repository.
3. Investigation summaries must be included in Annual Product Quality Review (APQR).

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• OOS: Out of Specification
• OOT: Out of Trend
• APQR: Annual Product Quality Review

7. Documents

1. OOS/OOT Investigation Report – Annexure-1
2. Repeat Testing Request Form – Annexure-2
3. Repeat Test Report – Annexure-3
4. Investigation Closure Form – Annexure-4

8. References

• ICH Q2(R1) – Validation of Analytical Procedures
• FDA Guidance on Out of Specification Results (October 2006)
• WHO TRS No. 996 – GMP for QC Labs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Analyst	QA Executive	Head QC
Department	Quality Control	Quality Assurance	Quality Control

11. Annexures

Annexure-1: OOS/OOT Investigation Report

Batch No.	Sample Type	Test Performed	OOS/OOT Observed	Initial Analyst
INJ-B120	Finished Product	Assay	OOS – Low Result	Meena R.

Annexure-2: Repeat Testing Request Form

Date	Reason for Repeat	Justification	Requested By
22/06/2025	Instrument Fluctuation	Power interruption mid-run	Meena R.

Annexure-3: Repeat Test Report

Test	Initial Result	Repeat Result	Analyst	Remarks
Assay	92.4%	98.1%	Ravi Jha	Accepted

Annexure-4: Investigation Closure Form

Investigation ID	Conclusion	Corrective Action	QA Reviewer
INV-0254	Power failure confirmed	UPS backup enhancement	Sunita Reddy

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
05/01/2022	1.0	Initial Issue	Procedure Introduction	Head QC
24/06/2025	2.0	Revised annexures, added instrument error cases	Annual SOP Review	Head QC