resolution of OOS results during in-process testing activities performed in the sterile manufacturing area.

3. Responsibilities

• Production Officer: Notifies QA/QC immediately upon observing an OOS result.
• QC Analyst: Conducts confirmatory testing and documents findings.
• QA Officer: Coordinates investigation, ensures proper documentation, and approves corrective actions.

4. Accountability

Head – Quality Assurance is accountable for ensuring effective implementation, investigation oversight, and resolution of OOS incidents.

5. Procedure

5.1 Identification of OOS Results

1. If any in-process test result deviates from pre-defined acceptance criteria, treat it as OOS.
2. Examples include deviations in filling volume, pH, osmolarity, visual inspection, etc.

5.2 Initial Response

1. Analyst shall immediately notify Production and QA.
2. Stop the related manufacturing activity until the root cause is identified or interim controls are implemented.
3. Segregate affected material and affix “Under Investigation” status label.

5.3 Phase I Investigation (Preliminary)

1. Verify the integrity and calibration status of equipment used.
2. Review the analyst’s method, training records, and raw data.
3. If assignable cause is found (e.g., analyst error, instrument malfunction), repeat test after correction with QA authorization.

5.4 Phase II Investigation (Comprehensive)

1. If no assignable cause is found, initiate formal investigation using OOS Investigation Form (Annexure-1).
2. Evaluate manufacturing conditions, environment, equipment logs, and batch records.
3. Form cross-functional team (QA, QC, Production, Engineering).

5.5 Confirmatory Testing

1. Perform retesting or re-sampling only when justified and approved by QA.
2. Retesting results must be documented in Retest Result Sheet (Annexure-2).

5.6 Corrective and Preventive Actions (CAPA)

1. Based on investigation outcome, define CAPA plan in Annexure-3.
2. QA shall ensure CAPAs are implemented and verified for effectiveness.

5.7 Final Review and Closure

1. QA Head shall review the investigation report, approve conclusion, and authorize product disposition.
2. Archive all records with batch documentation.

6. Abbreviations

• OOS: Out-of-Specification
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure

7. Documents

1. OOS Investigation Form – Annexure-1
2. Retest Result Sheet – Annexure-2
3. CAPA Implementation Log – Annexure-3

8. References

• USFDA Guidance for Industry – Investigating OOS Test Results
• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – CGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: OOS Investigation Form

Date	Batch No.	Test Parameter	Observed Value	Initial Response
17/06/2025	INJ-3201	Filling Volume	1.12 mL	Production halted

Annexure-2: Retest Result Sheet

Sample ID	Retest Value	Specification	Analyst	Remarks
R-3201	1.00 mL	1.00 ± 0.05 mL	SK	Within range

Annexure-3: CAPA Implementation Log

CAPA ID	Description	Responsible	Due Date	Status
CAPA-105	Calibrate nozzle sensor	Engineering	25/06/2025	Open

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Added detailed annexures for CAPA and retesting	Periodic Review	QA Head