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Description
Products on the market that are suspected or known to be seriously defective and/or pose a potential risk to patient health must be recalled. This must be done promptly, comprehensively and in accordance with any governmental health agency regulations and requirements governing distributed products.
This applies to all products manufactured and distributed from a site, including physician samples and commercial products used for market studies and clinical trials.
This 11-page SOP (Standard Operating Procedure)applies to all drug product and device manufacturers and describes the roles and responsibilities of the Recall Coordinator and the Recall Committee, as well as the order of events. It also includes 1 attachment - the recall decision flow chart.
Table of Content
1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Quality Head or Designee (Recall coordinator)
4.2 Recall Committee
5. Procedure
5.1 General
5.2 Preliminary Investigation and Information
5.3 Case Classifications
5.4 Factors to consider
5.4.1 Health Hazard
5.4.2 Depth of Recall
5.5 Recall Committee Meeting
5.6 Recall Documents
5.7 Public announcements
5.8 Recall Close out
5.9 Mock Recall
6. Definitions
7. Distribution
8. Attachment 1: Recall Decision Flow Chart
