Standard Operating Procedure for Handling of Out-of-Specification Results

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the handling and investigation of out-of-specification (OOS) results in pharmaceutical manufacturing to ensure product quality and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the testing, analysis, and reporting of analytical results within the pharmaceutical manufacturing facility. It covers procedures for OOS identification, investigation, documentation, and corrective actions.

3) Responsibilities

– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines for OOS handling.
– Quality Control (QC) Department: Identifies and investigates OOS results and proposes corrective actions.
– Production Department: Implements corrective actions and ensures product compliance before release.

4) Procedure

4.1 OOS Identification
4.1.1 Define criteria for identifying OOS results based on specifications and acceptance criteria.
4.1.2 Immediately quarantine any product associated with OOS results to prevent further distribution.
4.2 Preliminary Investigation
4.2.1 Conduct a preliminary review of the OOS result to determine potential causes and impacts.
4.2.2 Notify QA and QC management of the OOS result and initiate an investigation team if necessary.
4.3 Detailed Investigation
4.3.1 Initiate a detailed investigation to identify root causes of the OOS result using scientifically sound and documented approaches.
4.3.2 Perform additional testing or retesting if needed to support the investigation and confirm OOS findings.
4.4 Investigation Report
4.4.1 Prepare an OOS investigation report documenting investigation findings, root causes, and conclusions.
4.4.2 Obtain approvals from QA and QC management for the investigation report before proceeding with corrective actions.
4.5 Corrective Actions
4.5.1 Develop and implement corrective actions based on investigation findings to prevent recurrence of OOS results.
4.5.2 Verify effectiveness of corrective actions through follow-up testing and monitoring.
4.6 Documentation
4.6.1 Document all aspects of OOS handling, including initial notification, investigation records, and corrective action plans.
4.6.2 Ensure that all records are reviewed and approved by the QA department.
4.7 Reporting
4.7.1 Prepare a summary report of the OOS investigation, including findings, actions taken, and preventive measures.
4.7.2 Submit the report to the QA department for review, approval, and archiving.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– OOS: Out-of-Specification

6) Documents, if any

– OOS Investigation Report
– Corrective Action Plan
– Follow-Up Testing Records

7) Reference, if any

– FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
– EMA Guideline on the Investigation of Bioequivalence

8) SOP Version

Version 1.0