Product Recall Management

General

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

Word File

12 pages procedure