Standard Operating Procedure for Handling Out-of-Specification Results

1) Purpose

The purpose of this SOP is to establish procedures for the identification, investigation, and handling of out-of-specification (OOS) results to ensure product quality, data integrity, and compliance with regulatory requirements.

2) Scope

This SOP applies to all laboratory testing and manufacturing processes within the facility that may generate test results, including raw materials, in-process materials, and finished products.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Quality Control (QC) Analyst:

Responsible for identifying and reporting OOS results during testing.

3.2 Quality Assurance (QA) Specialist:

Responsible for overseeing the investigation and disposition of OOS results.

3.3 Production Supervisor:

Responsible for implementing corrective actions and preventing recurrence of OOS results.

4) Procedure

4.1 Identification of OOS Results:

4.1.1 Define OOS criteria and acceptance limits for each test.
4.1.2 Notify QA and Production Supervisor immediately upon identification of OOS results.
4.1.3 Secure and segregate the affected batch or sample for further investigation.

4.2 Investigation Process:

4.2.1 Form an investigation team including QC, QA, and Production representatives.
4.2.2 Conduct a thorough investigation to determine root cause(s) of the OOS result.
4.2.3 Document investigation findings and conclusions.

4.3 Out-of-Specification Report:

4.3.1 Prepare an OOS report detailing investigation findings, root cause analysis, and corrective actions.
4.3.2 Obtain approval of the OOS report from QA before proceeding with any corrective actions.
4.3.3 Communicate findings and actions to relevant stakeholders.

4.4 Corrective and Preventive Actions (CAPA):

4.4.1 Implement corrective actions to address identified root causes.
4.4.2 Develop preventive actions to prevent recurrence of OOS results.
4.4.3 Review and verify effectiveness of CAPA through follow-up and monitoring.

4.5 Documentation and Record Keeping:

4.5.1 Maintain accurate and complete records of all OOS investigations and actions taken.
4.5.2 Archive OOS records according to established document retention policies.
4.5.3 Provide OOS records during regulatory inspections and audits as required.

5) Abbreviations, if any

QC – Quality Control
QA – Quality Assurance

6) Documents, if any

1. OOS Investigation Report
2. Corrective and Preventive Action (CAPA) Plan
3. OOS Records
4. Training Records

7) Reference, if any

1. FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
2. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0