Standard Operating Procedure for Recall Procedure for Aerosols
1) Purpose
The purpose of this SOP is to define procedures for initiating and conducting product recalls of aerosol products when necessary to ensure consumer safety and regulatory compliance.
2) Scope
This SOP applies to all product recall activities for aerosol products marketed by [Company Name], including voluntary and mandatory recalls initiated due to safety concerns, quality issues, or regulatory non-compliance.
3) Responsibilities
Recall Coordinator: Oversee the recall process and coordinate activities with relevant departments.
Quality Assurance (QA) Team: Evaluate recall severity and determine appropriate recall classification (e.g., Class I, II, III).
Regulatory Affairs: Ensure compliance with regulatory requirements for product recalls and communicate with regulatory authorities.
Manufacturing Team: Provide technical support for identifying root causes of recall issues and implementing corrective actions.
4) Procedure
4.1 Recall Initiation:
4.1.1 Identify potential reasons for initiating a recall, such as safety concerns, quality defects, or regulatory violations.
4.1.2 Notify the Recall Coordinator and establish a recall committee if necessary to assess the situation.
4.1.3 Determine the scope of the recall, including affected batch numbers, distribution channels, and geographical locations.
4.2 Recall Classification:
4.2.1 Classify the recall based on risk assessment and regulatory guidelines (e.g., Class I, II, III) to determine the urgency and extent of recall actions.
4.2.2 Document the rationale for recall classification and notify regulatory authorities as required.
4.2.3 Implement appropriate measures to prevent further distribution or use of affected aerosol products.
4.3 Recall Strategy and Plan:
4.3.1 Develop a recall strategy and action plan, including communication strategies, recall notifications, and retrieval methods.
4.3.2 Assign responsibilities and designate recall team members for executing specific tasks during the recall process.
4.3.3 Prepare recall communications, including press releases, customer notifications, and regulatory agency notifications.
4.4 Recall Execution:
4.4.1 Initiate the recall process by issuing recall notifications to distributors, retailers, and consumers.
4.4.2 Coordinate product retrieval, replacement, or refund procedures with affected stakeholders.
4.4.3 Monitor the effectiveness of recall actions and ensure timely completion of recall activities.
4.5 Recall Close-Out and Evaluation:
4.5.1 Evaluate the effectiveness of the recall process, including retrieval rates and customer response.
4.5.2 Document the outcomes of the recall, including lessons learned and improvements for future recall preparedness.
4.5.3 Close out the recall process and notify regulatory authorities of completion, including final reports and documentation.
4.6 Communication and Reporting:
4.6.1 Communicate recall status updates to internal stakeholders, management, and regulatory authorities.
4.6.2 Prepare and submit required recall reports to regulatory agencies, including recall notification summaries and completion reports.
4.6.3 Maintain records of all recall activities, communications, and documentation for regulatory inspections and audits.
5) Abbreviations, if any
SOP: Standard Operating Procedure
Class I, II, III: Classification of recalls based on the level of health hazard posed by the product
6) Documents, if any
Recall Notification Letters
Recall Strategy and Action Plan
Recall Effectiveness Evaluation Reports
Communication Records (press releases, customer notifications)
Regulatory Agency Correspondence
7) Reference, if any
FDA Guidance for Industry: Product Recalls, Including Removals and Corrections
EMA Guideline on Good Distribution Practice of Medicinal Products for Human Use
ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
8) SOP Version
Version 1.0