We were just reviewing our notes from the HPRA GDP Compliance Information day and thought we would share some of them with you…

Darren Scully shared some of the deficiencies related to temperature mapping monitoring, which included:

• Wholesalers not following through on placement of monitoring loggers in line with their mapping results. Have you relocated your loggers? Give Claire (01-4666952) a call to check if your loggers are placed in line with your mapping studies.
• Wholesalers not taking a backward look at the impact on product of temperature excursions
• Wholesalers not calibrating their loggers in a timely manner. Call our support team (01 4666954) if you think you need to schedule your calibrations!

Alfred Hunt reminded us of our validation and qualification obligations, including:

• Identifying key processes
• Risk assess the critical steps
• Challenge the system
• Document

Alfred brought home to us why we are doing this work – to ensure we are confident we have the right system, that it operates as intended and that we can demonstrate this! He gave a useful example of a warehouse management system