Standard Operating Procedure for Product Recalls in Otic Manufacturing Unit
1) Purpose
To establish procedures for initiating, managing, and completing product recalls of Otic (Ear) Dosage Forms to protect public health and comply with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in identifying, assessing, initiating, and executing product recalls within the Otic manufacturing unit.
3) Responsibilities
Quality Assurance (QA) Department: Responsible for overseeing and coordinating product recall activities.
Quality Control (QC) Department: Responsible for assessing the need for recall based on quality issues.
Production Department: Responsible for providing necessary production records and batch information.
Regulatory Affairs Department: Responsible for notifying regulatory authorities as per applicable regulations.
4) Procedure
4.1 Recall Initiation
4.1.1 Identification of Recall
4.1.1.1 QA receives information about potential quality issues or safety concerns.
4.1.1.2 Assess the need for recall based on risk assessment and severity of issue.
4.1.2 Recall Decision
4.1.2.1 QA collaborates with QC and Regulatory Affairs to determine recall classification (voluntary or mandatory).
4.1.2.2 Notify senior management and obtain approval for recall initiation.
4.2 Recall Strategy and Execution
4.2.1 Recall Strategy Development
4.2.1.1 Develop a detailed recall plan outlining objectives, scope, and communication strategy.
4.2.1.2 Define roles and responsibilities of recall team members.
4.2.2 Communication Plan
4.2.2.1 Notify affected customers, distributors, and regulatory authorities promptly.
4.2.2.2 Provide clear instructions for return, replacement, or refund of recalled products.
4.3 Recall Implementation
4.3.1 Product Retrieval
4.3.1.1 Coordinate with logistics and distribution teams to retrieve recalled products.
4.3.1.2 Ensure segregation and secure storage of recalled products.
4.3.2 Investigation and Root Cause Analysis
4.3.2.1 QC conducts thorough investigation to determine root cause of the issue.
4.3.2.2 Document findings and implement corrective actions to prevent recurrence.
4.4 Completion and Closure
4.4.1 Effectiveness Check
4.4.1.1 Evaluate effectiveness of recall actions and completeness of product retrieval.
4.4.1.2 Close recall process after confirming all required actions are completed.
4.4.2 Documentation and Reporting
4.4.2.1 Maintain detailed records of recall activities, including communication logs and investigation reports.
4.4.2.2 Prepare and submit final recall report to regulatory authorities as required.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
Recall plan
Communication templates
Investigation reports
Final recall report
7) Reference, if any
GMP guidelines for product recalls in pharmaceutical manufacturing
8) SOP Version
Version 1.0