Standard Operating Procedure for Recall Procedures

1) Purpose

The purpose of this SOP is to establish a procedure for initiating, implementing, and managing product recalls to ensure timely and effective removal of defective or potentially harmful products from the market.

2) Scope

This SOP applies to all personnel involved in the pharmaceutical manufacturing facility responsible for managing and executing product recalls.

3) Responsibilities

3.1 Quality Assurance (QA) Manager
– Oversee and coordinate the recall process.
– Ensure compliance with regulatory requirements and company policies.
3.2 Regulatory Affairs
– Assess regulatory impact and requirements for product recall.
– Communicate with regulatory authorities as necessary.
3.3 Production Manager
– Provide support for the recall process, including information on manufacturing and distribution.
3.4 Customer Service Representative
– Receive and document customer complaints related to recalled products.

4) Procedure

4.1 Recall Initiation
4.1.1 Identify the need for a recall based on internal reports, customer complaints, or regulatory requests.
4.1.2 Notify the QA Manager and Regulatory Affairs of the recall initiation.
4.2 Recall Strategy Development
4.2.1 Formulate a recall strategy including scope, classification, and urgency of the recall.
4.2.2 Determine the recall depth (e.g., wholesale level, retail level) and geographic extent.
4.3 Notification and Communication
4.3.1 Prepare a recall notification letter detailing the reason for recall, product description, and actions required by stakeholders.
4.3.2 Distribute recall notifications to affected parties, including distributors, retailers, and regulatory agencies.
4.4 Recall Execution
4.4.1 Monitor and track the progress of the recall, including retrieval of recalled products from the market.
4.4.2 Document all actions taken during the recall process, including product disposition and destruction.
4.5 Effectiveness Check
4.5.1 Evaluate the effectiveness of the recall by monitoring the return of recalled products.
4.5.2 Conduct a root cause analysis to prevent recurrence of similar issues.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Recall Notification Letters
– Recall Effectiveness Reports
– Recall Log

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