Standard Operating Procedure for Recall Procedures in Ointment Formulation
1) Purpose
The purpose of this SOP is to establish procedures for initiating and conducting product recalls in the event of quality defects or safety concerns related to ointment products.
2) Scope
This SOP applies to all personnel involved in the recall process, including production, quality assurance, regulatory affairs, and distribution.
3) Responsibilities
– Quality Assurance (QA): Responsible for initiating and coordinating the recall process.
– Production Staff: Responsible for providing information on affected batches and production records.
– Regulatory Affairs: Responsible for communicating with regulatory authorities as required.
4) Procedure
1. Identification of Recall Situation:
1.1 Internal Notification:
1.1.1 Immediately notify QA and senior management upon identifying a potential recall situation.
1.1.2 Provide details such as product name, batch numbers, reason for recall, and potential risks.
1.2 Risk Assessment:
1.2.1 Conduct a risk assessment to determine the severity and scope of the recall.
1.2.2 Classify the recall according to regulatory guidelines (e.g., Class I, II, III).
2. Recall Strategy Development:
2.1.1 Develop a written recall plan outlining the objectives, strategy, and responsibilities.
2.1.2 Include procedures for product retrieval, segregation, and disposal.
2.2 Communication Strategy:
2.2.1 Determine communication channels and stakeholders (internal and external) to be informed.
2.2.2 Draft communication materials, including press releases and customer notifications.
3. Implementation of Recall:
3.1 Recall Execution:
3.1.1 Initiate product retrieval and segregation from distribution channels.
3.1.2 Ensure affected products are securely stored to prevent further distribution.
3.2 Documentation:
3.2.1 Document all actions taken during the recall process, including timelines and outcomes.
3.2.2 Maintain records of communication with regulatory authorities and stakeholders.
4. Closure of Recall:
4.1 Effectiveness Check:
4.1.1 Verify the effectiveness of the recall through reconciliation of returned products.
4.1.2 Assess any remaining risks and take corrective actions as necessary.
4.2 Final Report:
4.2.1 Prepare a final recall report summarizing the recall activities and outcomes.
4.2.2 Submit the report to regulatory authorities and maintain a copy for internal records.
5) Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
6) Documents, if any
– Recall Plan
– Communication Materials
– Recall Effectiveness Reports
– Final Recall Report
7) Reference, if any
– FDA Guidance for Industry: Product Recalls, Including Removals and Corrections
– ICH Q9: Quality Risk Management
8) SOP Version
Version 1.0