Hi All,

I believe all of you have identified so many ways that post market surveillance can be conducted. The main pitfall that I have seen manufacturers fall in most of the time is the understanding of the term post-market. Post-Market means after obtaining marketing authorizations from regulatory agencies, not when you actually market the product. So if the manufacturer obtained authorization to market the product, but have not yet introduced the product tot the market, the manufacturer is still required to conduct post-market surveillance. From my experience, I have seen post-market surveillance conducted in many ways including:
– Customer complaint or Product Quality Complaint data analysis and trending
– Product Related Adverse Event analysis and Trending (Sometimes referred to as Periodic Safety Update Report)
– Manufacturing Performance Monitoring – I have seen manufacturers conduct an annual analysis to determine Process deficiencies and any unexpected manufacturing issues.
– Annual satisfaction surveys sent to customers to obtain customer feedback

All these information are usually reviewed during the management review for each product or product family.