Standard Operating Procedure for Deviation and Out-of-Specification (OOS) Handling in Otic Manufacturing Unit
1) Purpose
To establish procedures for handling deviations and out-of-specification (OOS) results encountered during the manufacturing, testing, or packaging of Otic (Ear) Dosage Forms to ensure product quality, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to all deviations and OOS results identified within the Otic manufacturing unit, including but not limited to manufacturing processes, analytical testing, and packaging operations.
3) Responsibilities
Quality Assurance (QA) Department: Responsible for oversight and management of deviation and OOS investigations.
Quality Control (QC) Department: Responsible for initiating and conducting investigations into OOS results.
Production Department: Responsible for implementing corrective and preventive actions (CAPAs) as directed by QA.
4) Procedure
4.1 Deviation Reporting
4.1.1 Identification
4.1.1.1 Personnel identify and document any deviation from approved procedures or specifications.
4.1.1.2 Classify deviations based on severity and potential impact on product quality.
4.1.2 Initial Assessment
4.1.2.1 QA reviews and assesses the deviation report for completeness and initial impact assessment.
4.1.2.2 Assign a unique deviation number and initiate investigation.
4.2 Investigation and Root Cause Analysis
4.2.1.1 Form an investigation team including representatives from QA, QC, and relevant departments.
4.2.1.2 Conduct a thorough investigation to determine the root cause of the deviation or OOS result.
4.2.2 Root Cause Analysis
4.2.2.1 Use appropriate tools and methodologies (e.g., fishbone diagram, 5 Whys) to identify the root cause.
4.2.2.2 Document findings and conclusions from the investigation.
4.3 Corrective and Preventive Actions (CAPAs)
4.3.1 CAPA Plan
4.3.1.1 Develop a CAPA plan to address identified root causes and prevent recurrence.
4.3.1.2 Assign responsibilities and establish timelines for CAPA implementation.
4.3.2 Implementation
4.3.2.1 Implement CAPAs promptly and effectively across relevant departments.
4.3.2.2 Monitor implementation progress and document updates.
4.4 Documentation and Reporting
4.4.1 Deviation Report
4.4.1.1 Document all investigation findings, actions taken, and outcomes in the deviation report.
4.4.1.2 Obtain approval from QA before closing the deviation report.
4.4.2 OOS Investigation Report
4.4.2.1 Prepare an OOS investigation report detailing analytical findings and conclusions.
4.4.2.2 QA reviews and approves the OOS investigation report.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
OOS: Out-of-Specification
CAPA: Corrective and Preventive Actions
6) Documents, if any
Deviation report form
OOS investigation report template
CAPA plan template
7) Reference, if any
GMP guidelines for deviation and OOS handling in pharmaceutical manufacturing
8) SOP Version
Version 1.0
