Product Recall Management

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Product Recall Management

Quick Overview

This Standard Operating Procedure (SOP) describes the program necessary to assure that a product recall is conducted prompt, complete and in accordance with any governmental health agencies regulations and requirements of distributed product that is suspected or known by management to be seriously defective, and/or pose potential health risk to patients.

Product Recall Management

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This procedure applies to all products manufactured and distributed from this Site. This includes physician samples and commercial product used for market studies


Regulatory basis, reference documents´╗┐


  • FDA: FDA: 21 CFR 211.150
  • EMA: EU Directive for GMP’s



Table of Content (just Headers):


1          Purpose

2          Objective

3          Regulatory basis, reference documents

3.1       Company Management

3.2       Quality Management Representative / Quality Assurance / (Recall coordinator)

3.3       Recall Committee

4          Related documents

5          Definitions

6          Procedure

6.1       General

6.2       Preliminary Investigation and Information

6.3       Case Classifications

6.4       Key Factors

6.4.1    Health Hazard           

6.4.2    Depth of Recall

6.4.3    Recall Committee Meeting

6.4.4    Recall Documents

6.4.5    Public announcements

6.4.6    Recall Close out

6.4.7    Mock Recall

7          Attachments

7.4       Attachment 1: Recall Decision Flow Chart

8          SOP distribution

9          Health, safety and environmental considerations


Size and Format:


    Microsoft Office 2003

    Word File

    12 pages procedure

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