Key-person risk in GDP medical logistics

Good Distribution Practice requires that temperature, custody and documentation stay under control from the warehouse to the patient. In many logistics operations that control rests on a few experienced dispatchers.

Where does dependency concentrate in GDP logistics?

• Temperature excursions. An alarm reaches a person, and the deviation record waits until that person has time.
• Chain of custody. Hand-offs are recorded after the fact.
• Temperature records. Readings are written down instead of taken from a logger.
• Shipment status. Updates are keyed in by people instead of received from carrier or GPS feeds.
• GDP and customs documents. Each shipment's papers are prepared by hand by one specialist.

Which KPIs does the screening use for GDP logistics?

• Excursion response time: hours from a temperature excursion alarm to a deviation record opened in the quality system.
• Chain-of-custody documentation lag: hours between a custody hand-off and its record in the tracking system.
• Manual temperature records: share of temperature records created by hand instead of taken from a logger or monitoring system.
• Manual shipment updates: share of shipment status updates keyed in by people instead of received from GPS, carrier or transport-management feeds.
• GDP and customs document preparation: hands-on staff hours to prepare the GDP and customs documents for one shipment.

If you do not have a figure, the screening uses the industry median.

What does the audit look at in GDP logistics?

The workshop follows one temperature-controlled shipment and asks who has to act at each point, especially outside office hours. Typical findings concern excursion handling that depends on one dispatcher and documents that only one person can prepare.

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