GDP

Question 1

GDP - Temperature Controlled Facilities/Warehouse

Answer 1

Storage areas should be temperature mapped under representative conditions and take into account seasonal variations. Mapping should be repeated on a risk based approach or following significant modifications to the warehouse or temperature monitoring equipment. Calibrate across range of use.
Storage areas should be temperature and RH monitored/recorded. Monitor in extremes of warehouse. If extremes OK provides confidence other areas OK.
Alarms if go out of conditions  trended.
Regular calibration of temperature monitoring devices and consideration given to annual remapping of storage areas.
Level of control depends on products being stored  typically temperature controlled and RH monitored but this depends on products being stored.
Separate area for blocked/rejected stock.
Printed packaging components should be stored securely.
Access limited and controlled.
If temperature controlled shipment is required temperature should be monitored/recorded during shipment by use of dataloggers/validated shipping containers. Need method of checking for excursions on receipt of product and conducting assessment on any excursions.

Question 2

GDP labelled storage conditions

Answer 2

Uncontrolled
No label storage conditions
Controlled conditions
Ambient: 15-30C
Cold Chain: 2-8C
Frozen: <-15C
Cryogenic: <-70C

Question 3

GDP Transport Routes

Answer 3

Transport Routes
Air
Road
Boat
36 hrs max time at transportation hub
Customs risk area: delays  how to ensure product stays within required conditions

Question 4

GDP Responsible Person

Answer 4

Responsible for QMS at wholesalers/distributors
Named on WDA
Approve returns to stock