Standard Operating Procedure for Out of Specification (OOS) Handling in Gels Production

1) Purpose

The purpose of this SOP is to establish procedures for the identification, investigation, and handling of Out of Specification (OOS) results encountered during gels production, ensuring accurate data interpretation, product quality assessment, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s gels production department, including Quality Assurance (QA), Quality Control (QC), and Production personnel responsible for OOS investigations.

3) Responsibilities

Quality Assurance (QA) Team: Oversee OOS investigation process and ensure compliance with SOPs.
Quality Control (QC) Analysts: Perform initial OOS investigation and data review.
Production Supervisors: Provide support and necessary information for OOS investigations.

4) Procedure

4.1 OOS Result Identification
4.1.1 Identify and document any test result that falls outside established acceptance criteria or specifications.
4.1.2 Classify the OOS result based on significance and potential impact on product quality.

4.2 Initial Assessment and Documentation
4.2.1 Conduct a preliminary assessment of the OOS result to ensure it is not due to laboratory error or testing deviation.
4.2.2 Document the OOS result including test conditions, equipment used, and any relevant observations.

4.3 Full Investigation
4.3.1 Initiate a thorough investigation to identify the root cause(s) of the OOS result using systematic root cause analysis techniques.
4.3.2 Evaluate potential factors such as raw materials, equipment, personnel, and environmental conditions.

4.4 Corrective Actions
4.4.1 Propose and implement appropriate corrective actions to address identified root causes and prevent recurrence.
4.4.2 Obtain approval from designated personnel, such as QA Manager or Production Manager, for implementation of corrective actions.

4.5 Documentation and Reporting
4.5.1 Document all OOS investigation activities, including findings, corrective actions taken, and verification of effectiveness.
4.5.2 Report OOS results, investigation outcomes, and corrective actions to relevant stakeholders and regulatory authorities as required.

4.6 Review and Closure
4.6.1 Review the completed OOS investigation report and ensure all required documentation is accurate and comprehensive.
4.6.2 Close the OOS investigation after confirming that corrective actions have been effective and documented appropriately.

5) Abbreviations, if any

SOP: Standard Operating Procedure
OOS: Out of Specification
QA: Quality Assurance
QC: Quality Control

6) Documents, if any

– OOS Investigation Report Form
– Root Cause Analysis Reports
– Corrective and Preventive Action (CAPA) Plans and Reports

7) Reference, if any

– FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
– EU GMP Annex 1: Manufacture of Sterile Medicinal Products
– Company-specific OOS handling procedures and guidelines

8) SOP Version

Version 1.0