Standard Operating Procedure for Recall Procedure for Transdermal Patches
1) Purpose
To establish procedures for initiating, implementing, and managing product recalls of transdermal patches to mitigate risks to patient safety and comply with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the recall process, including quality assurance (QA), regulatory affairs, production, logistics, and senior management.
3) Responsibilities
3.1 QA Manager: Oversees the entire recall process and ensures timely execution.
3.2 Regulatory Affairs: Ensures compliance with regulatory requirements and notifies regulatory authorities as necessary.
3.3 Production Manager: Coordinates the recall process within the production facility.
3.4 Logistics: Manages the retrieval and disposal of recalled products.
3.5 Senior Management: Provides oversight and approves the recall strategy and communications.
4) Procedure
4.1 Recall Initiation:
4.1.1 Identify the need for a recall based on reported issues, complaints, or regulatory findings.
4.1.2 Formulate a recall committee comprising relevant stakeholders to manage the recall process.
4.2 Recall Strategy:
4.2.1 Develop a recall strategy, including scope, classification, and determination of the recall level (e.g., Class I, II, III).
4.2.2 Establish communication channels
4.3 Notification:
4.3.1 Notify regulatory authorities as per local regulations and guidelines.
4.3.2 Inform customers, distributors, and healthcare professionals about the recall, including the reason, risk assessment, and actions to be taken.
4.4 Product Retrieval:
4.4.1 Implement procedures to retrieve recalled products from the market, including distributors and customers.
4.4.2 Quarantine and segregate recalled products to prevent unintended distribution.
4.5 Disposal or Correction:
4.5.1 Decide on the appropriate action for recalled products (e.g., disposal, repair, rework).
4.5.2 Document the disposal or correction process and ensure compliance with environmental regulations.
4.6 Effectiveness Check:
4.6.1 Conduct effectiveness checks to verify the success of the recall process.
4.6.2 Evaluate corrective actions and preventive measures to prevent recurrence.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Recall Notification Letters
Recall Effectiveness Reports
Regulatory Correspondence
7) Reference, if any
FDA Guidance for Industry: Product Recalls, Including Removals and Corrections
EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use
8) SOP Version
Version 1.0
