Standard Operating Procedure for Out-of-Specification (OOS) Results Investigation

Department	Tablet
SOP No.	SOP/TAB/181/2025
Supersedes	SOP/TAB/181/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To establish procedures for the investigation of Out-of-Specification (OOS) results in tablet production, ensuring proper identification, documentation, and corrective actions to maintain product quality and regulatory compliance.

2. Scope

This SOP applies to all OOS results observed during any stage of tablet production, including raw material testing, in-process controls, and final product testing. It covers the investigation process, including identification, documentation, corrective actions, and reporting.

3. Responsibilities

• Quality Assurance (QA): Responsible for overseeing the investigation of OOS results, reviewing investigation reports, and ensuring corrective actions are implemented.
• Quality Control (QC): Responsible for identifying and reporting OOS results, performing re-tests when necessary, and providing data for the investigation.
• Production Supervisors: Ensure that all relevant process information is provided during the OOS investigation and assist in identifying potential causes.
• All Personnel: Report any OOS results promptly to QA and assist with gathering information for the investigation as necessary.

4. Accountability

The QA Manager is accountable for ensuring that OOS results are properly investigated, documented, and resolved. The Production Manager is accountable for implementing corrective actions and ensuring that the process remains in control.

5. Procedure

5.1 Identification of OOS Results

1. Any test result that falls outside the established specification limits, whether during raw material testing, in-process testing, or final product testing, should be immediately flagged as an OOS result.
2. OOS results can be identified by any member of the QC team, production team, or through data monitoring systems.
3. Ensure that all OOS results are reported promptly to QA and documented in the appropriate record (e.g., Batch Record, Laboratory Test Report).

5.2 Initial Review

1. The QA team will perform an initial review of the OOS result to determine if the result is valid or if it may have been caused by external factors such as human error, equipment malfunction, or improper testing conditions.
2. Verify the accuracy of the test procedure, equipment calibration, and testing conditions.
3. If the OOS result is due to a testing error or procedural mistake, perform a re-test or take corrective actions as necessary.
4. If the OOS result is confirmed, proceed with a full investigation as outlined in the procedure.

5.3 Investigation Process

1. The QA team will initiate an investigation to determine the root cause of the OOS result. This includes reviewing all relevant data, such as raw material specifications, batch records, production logs, and test data (Annexure-1).
2. Conduct an investigation to determine if the OOS result is due to:
   • Raw material variability
   • Production process deviations
   • Equipment malfunction
   • Environmental conditions (e.g., temperature, humidity)
   • Human error
3. Interview relevant personnel to gather information about any deviations or anomalies during production.
4. If the root cause of the OOS result is identified, take corrective actions to address the issue. This may include revising procedures, retraining personnel, or repairing equipment.

5.4 Documentation of Investigation

1. Document the results of the investigation, including the OOS result, the investigation process, root cause analysis, and corrective actions taken (Annexure-2).
2. Ensure that the investigation report includes:
   • A detailed description of the OOS result
   • Steps taken during the investigation
   • Root cause analysis
   • Corrective actions taken
   • Any preventive actions recommended
3. Submit the investigation report to the QA Manager for review and approval.

5.5 Corrective and Preventive Actions (CAPA)

1. Upon identification of the root cause, the necessary corrective actions should be implemented immediately to prevent recurrence of the issue.
2. In addition to corrective actions, preventive actions should be considered to prevent similar issues in the future, such as procedural changes, retraining, or equipment upgrades (Annexure-3).
3. Document all corrective and preventive actions, including timelines for implementation and persons responsible for completing the actions.
4. Review the effectiveness of the corrective and preventive actions through follow-up audits or testing.

5.6 Re-testing and Disposition of Affected Batch

1. If applicable, conduct re-testing of the affected batch to determine whether the OOS result was isolated or represents a systemic issue.
2. Once the root cause is identified and corrective actions are implemented, determine the disposition of the affected batch, which may include:
   • Release if within acceptable limits
   • Rework if feasible
   • Reject if non-compliant with specifications
3. Document the final disposition of the batch and update the batch record accordingly.

5.7 Reporting and Communication

1. Ensure that the investigation findings, corrective actions, and disposition decisions are communicated to the relevant departments, including production, QC, and regulatory affairs, as needed.
2. Report significant OOS findings and actions to regulatory authorities if required by regulatory guidelines or standards.

6. Abbreviations

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

7. Documents

1. Investigation Report (Annexure-1)
2. Corrective and Preventive Action Plan (Annexure-2)
3. CAPA Records (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Investigation Report

Batch Number	Test Parameter	OOS Result	Investigation Findings	Corrective Action Taken
Batch-12345	Tablet Hardness	Below specification	Equipment malfunction during compression	Recalibrated equipment, retrained operators

Annexure-2: Corrective and Preventive Action Plan

Action ID	Non-Conformity	Corrective Action	Preventive Action	Completion Date
CAPA-001	Tablet weight variation	Adjusted compression force	Reviewed and revised compression process	01/04/2026

Annexure-3: CAPA Records

CAPA ID	Issue Description	Corrective Action	Preventive Action	Completion Date
CAPA-002	OOS in dissolution test	Revised testing procedure	Revised equipment maintenance schedule	15/04/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated investigation procedures	Clarified CAPA process	QA Head