Recall Procedures for Defective or Non-Compliant Products

1) Purpose

The purpose of this SOP is to establish a standardized procedure for recalling defective or non-compliant products from the market to ensure consumer safety and compliance with regulatory requirements.

2) Scope

This SOP applies to all products distributed by the pharmaceutical manufacturing facility.

3) Responsibilities

– QA personnel are responsible for coordinating recall activities.
– QC personnel are responsible for providing technical support and investigation.
– Distribution personnel are responsible for handling logistics and communication with customers and regulatory bodies.

4) Procedure

1. Initiating a Recall
1.1. Identify the need for a recall based on product complaints, adverse event reports, or internal quality audits.
1.2. QA personnel should convene a recall committee to assess the situation and determine the recall strategy.
2. Classification of Recall
2.1. Classify the recall based on the severity of the issue:
2.1.1. Class I: Situations where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
2.1.2. Class II: Situations where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
2.1.3. Class III: Situations where use of, or exposure to, a violative product is not likely to cause adverse health consequences.
3. Notification
3.1. Notify relevant regulatory authorities about the recall, including details of the product, nature of the defect, and the recall strategy.
3.2. Notify customers and distributors, providing instructions for returning or destroying the affected product.
4. Recall Execution
4.1. Coordinate the return of the affected product from the market, ensuring all recalled products are securely transported and stored.
4.2. Track the quantity of recalled products and document the entire process.
5. Investigation and Root Cause Analysis
5.1. Conduct a thorough investigation to identify the root cause of the defect or non-compliance.
5.2. Use appropriate root cause analysis tools, such as fishbone diagrams, 5 Whys, or failure mode and effects analysis (FMEA).
6. Corrective and Preventive Actions (CAPA)
6.1. Develop a CAPA plan to address the root cause of the recall.
6.2. Implement corrective actions to prevent recurrence of the issue.
6.3. Document all actions taken in the CAPA report.
7. Documentation
7.1. Maintain detailed records of the recall process, including notifications, returned product quantities, investigation findings, and CAPA.
7.2. Sign and date all entries in the recall records.
8. Review and Approval
8.1. Submit the completed recall records and CAPA report to the QA department for review.
8.2. QA will review and approve the results, ensuring that all necessary actions have been taken and that the recall has been properly executed.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Recall Notification Template
– Recall Log
– CAPA Report Form

7) Reference, if any

– FDA 21 CFR Part 7 – Enforcement Policy
– WHO Guidelines on Recall Procedures for Pharmaceutical Products

8) SOP Version

Version 1.0