during any phase of testing at the API manufacturing facility.

3. Responsibilities

• QC Analyst: Identify and report OOS results immediately and initiate documentation.
• QC Reviewer: Confirm the validity of the result and initiate investigation if required.
• QA Officer: Participate in investigation, approve corrective/preventive actions, and close the OOS record.
• Department Head (QC/QA): Review the investigation, assess impact, and approve final disposition.

4. Accountability

The Head – Quality Assurance is accountable for ensuring timely and compliant investigation and resolution of all OOS events in accordance with regulatory expectations and internal SOPs.

5. Procedure

5.1 Identification of OOS

1. An OOS result is defined as any test result that falls outside the approved specification or acceptance criteria.
2. OOS results may arise during testing of:
   • Raw materials
   • In-process materials
   • Finished APIs
   • Stability samples
3. Analyst must immediately inform the QC supervisor and record the result in the OOS Notification Form (Annexure-1).

5.2 Phase I: Laboratory Investigation

1. Review the analytical method, calculation, raw data, instrument logs, reagents, and analyst’s technique.
2. Perform a system suitability check.
3. If no obvious errors are found, repeat the test using the same sample preparation (if stable).
4. If the repeat result is within limits and there is an assignable error, document and conclude.
5. If the repeat result is still OOS or the cause is not found, proceed to Phase II.

5.3 Phase II: Full-Scale Investigation

1. QA initiates a formal investigation using OOS Investigation Form (Annexure-2).
2. Investigate:
   • Manufacturing process deviations
   • Sample mix-up or contamination
   • Storage conditions
   • Previous batch trends and history
3. Interview involved personnel and document findings.
4. Define root cause and propose CAPA (Corrective and Preventive Action).
5. QA reviews and approves the investigation report.

5.4 Re-sampling and Re-testing Criteria

1. Re-sampling is allowed only if there is evidence of sample compromise or handling error.
2. Re-testing is permitted under QA-approved protocol with documented justification.
3. Original OOS result cannot be disregarded unless invalidated with scientifically sound reason.

5.5 Final Disposition

1. Based on investigation outcome, QA recommends:
   • Batch rejection
   • Reprocessing or re-testing
   • Product recall or reporting to regulatory authorities (if applicable)
2. Final decision is documented in the OOS Final Disposition Log (Annexure-3).

5.6 Trending and Review

1. QA shall review all closed OOS records quarterly to identify recurring issues.
2. Prepare trend reports and present during management review meetings.

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 Notification Form (Annexure-1)
2. OOS Investigation Form (Annexure-2)
3. OOS Final Disposition Log (Annexure-3)
4. CAPA Register

8. References

• US FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results
• ICH Q7 – GMP for APIs
• 21 CFR Part 211
• MHRA GxP Data Integrity Guidance

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 Notification Form

Date	Sample ID	Test	Result	Limit	Analyst	Supervisor Signature
13/04/2025	API-20250413	Assay	91.2%	95–105%	Sunita Reddy	Rajesh Kumar

Annexure-2: OOS Investigation Form

Investigation No.	OOS/025/2025
Details of Deviation	Assay below limit
Root Cause	Weighing error during sample prep
CAPA Proposed	Retraining of analysts, balance calibration check
QA Review Comments	Adequate and accepted

Annexure-3: OOS Final Disposition Log

Date	Sample ID	Result	Disposition	QA Sign
15/04/2025	API-20250413	OOS Confirmed	Batch Rejected	QA Head

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP	Regulatory Compliance	QA Head
13/04/2025	2.0	Added trending and disposition log	Internal Audit Observation	QA Head