Standard Operating Procedure for Recall Procedure for Gels
1) Purpose
The purpose of this SOP is to establish procedures for the initiation, execution, and documentation of product recalls for gels to promptly remove products from the market that pose a risk to public health or do not meet quality standards, ensuring compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s Quality Assurance (QA), Regulatory Affairs, Production, Logistics, and other relevant departments responsible for managing and executing product recalls for gels.
3) Responsibilities
Quality Assurance (QA): Initiate and oversee the recall process, ensuring compliance with SOPs and regulatory requirements.
Regulatory Affairs: Communicate with regulatory authorities regarding the recall and ensure compliance with regulatory reporting obligations.
Production: Provide technical expertise and support in identifying root causes and implementing corrective actions.
Logistics: Manage logistics and coordination of recalled products, including retrieval, transportation, and disposal.
4) Procedure
4.1 Recall Initiation
4.1.1 Identify the need for a recall based on internal quality monitoring, customer complaints, adverse event reports, or regulatory findings.
4.1.2 Notify the QA department immediately upon identification of a potential recall situation.
4.2 Recall Strategy Development
4.2.1 Formulate a recall strategy, including
4.2.2 Classify the recall according to severity and risk assessment (e.g., Class I, II, III) based on the potential harm posed by the product.
4.3 Notification and Communication
4.3.1 Notify relevant internal departments and stakeholders (QA, Regulatory Affairs, Production, Logistics) about the recall decision and strategy.
4.3.2 Prepare communication materials, including recall notifications, press releases, and customer letters, ensuring clarity and accuracy of information.
4.4 Execution of Recall
4.4.1 Coordinate with logistics to retrieve recalled products from distributors, wholesalers, pharmacies, and consumers.
4.4.2 Segregate and secure recalled products to prevent further distribution or use.
4.5 Investigation and Root Cause Analysis
4.5.1 Conduct an investigation to determine the root cause(s) of the quality issue or safety concern leading to the recall.
4.5.2 Implement corrective actions to address identified root causes and prevent recurrence.
4.6 Regulatory Reporting
4.6.1 Report the recall to regulatory authorities in accordance with applicable regulations and timelines.
4.6.2 Provide regulatory authorities with updates and progress reports throughout the recall process as required.
4.7 Effectiveness Check and Closure
4.7.1 Verify the effectiveness of the recall process through reconciliation and documentation of returned products.
4.7.2 Close the recall process upon completion of all required actions and approvals from QA and Regulatory Affairs.
4.8 Documentation and Archiving
4.8.1 Maintain comprehensive documentation of the recall process, including initiation, strategy, communications, investigations, corrective actions, and regulatory submissions.
4.8.2 Archive recall documentation in accordance with company procedures and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
– Recall Strategy Document
– Recall Notifications and Communications
– Investigation Reports and Root Cause Analyses
– Regulatory Submission Records
7) Reference, if any
– FDA Guidance for Industry: Product Recalls, Including Removals and Corrections
– ICH Guidelines for Pharmaceutical Quality Systems
– Company-specific recall procedures and guidelines
8) SOP Version
Version 1.0