Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products - Annex 9
TABLE OF CONTENTS
1.1 Port handling and customs clearance
1.1.3 Temporary storage at port of entry
3.3 Loading and receiving bays
3.4 Goods assembly and quarantine areas
3.4.2 Holding area for incoming goods
3.5 Environmental control of ancillary areas
3.6.1 General building security
3.6.2 Controlled and hazardous substances areas
3.7.1 Fire protection equipment
3.7.2 Fire prevention, detection and control procedures
3.9.1 Uninterrupted power supply
3.9.2 Power failure contingency plan
4. Temperature-controlled storage
4.2 Storage capacity of temperature-controlled stores
4.3 Temperature-controlled storage
4.4 Temperature-controlled storage for controlled and hazardous products
4.5 Temperature and humidity control and monitoring in storage
4.7 Qualification of temperature-controlled stores
4.8 Cleanliness of temperature-controlled stores
4.9 Refrigeration equipment maintenance
4.10 Calibration and verification of control and monitoring devices
4.10.1 Calibration of temperature control and monitoring devices
4.10.2 Calibration of humidity control and monitoring devices
4.10.3 Alarm equipment verification
5.1 Materials handling equipment
6.2 Product stability profiles
6.3 Transport route profiling and qualification
6.4 Temperature-controlled transport
6.4.2 Temperature-controlled road vehicles operated by common carriers
6.4.3 Temperature-controlled road vehicles generally
6.4.4 Transport of controlled TTSPPs and TTSPPs with high illicit value
6.5 Temperature and humidity control and monitoring during transit
6.5.1 Temperature control in temperature-controlled road vehicles
6.5.2 Temperature monitoring in temperature-controlled road vehicles
6.5.3 Humidity monitoring in temperature-controlled road vehicles
6.5.4 Temperature monitoring in passive and active shipping containers
6.6 Qualification of temperature-controlled road vehicles
6.7 Calibration and verification of transport monitoring devices
6.7.1 Calibration of transport temperature control devices
6.7.2 Calibration of transport temperature monitoring devices
6.7.3 Calibration of transport humidity monitoring devices
6.7.4 Verification of transport alarm equipment
6.8.1 Container selection generally
6.8.3 Qualification of insulated passive containers
6.8.4 Qualification of active containers
6.9 Shipping container packing
6.10 Product handling during packing and transport
6.11 Cleaning road vehicles and transport containers
6.12 Transport of returned and recalled TTSPPs
6.12.1 Transport of returned TTSPPs
6.12.2 Transport of recalled TTSPPs
7.2.2 Labelling air-freighted shipments
8.1.1 General stock control systems and procedures
8.1.2 Stock control procedures for controlled and hazardous TTSPPs
8.2.2 Actions following arrival checks
8.3 Outgoing goods (external deliveries)
8.3.1 Management of outgoing goods
8.3.2 Actions following dispatch
8.4 Product complaint procedures
8.5 Suspect product procedures
8.6 Product return, recall, withdrawal and disposal procedures
8.7 Traceability or stock tracking
9. General procedures and record-keeping
9.1 Emergencies and contingency planning
9.2.3 Record review and retention
9.3 Temperature and humidity records
10.2 Environmental management of refrigeration equipment
11.3.3 Contractors subject to service level agreements
11.4 Management of documents and standard operating procedures
11.4.1 Standard operating procedures
Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products - Annex 9:
