Model guidance for the storage and transport - Annex 9

Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products - Annex 9

Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products/Annex 9, These guidelines set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSPPs).
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Key to conventions used



Key to conventions used

1. Importation

1.1 Port handling and customs clearance

1.1.1 Port of entry

1.1.2 Offloading

1.1.3 Temporary storage at port of entry

1.1.4 Customs clearance

2. Warehousing sites

2.1 Site layout

2.1.1 Natural hazards

2.1.2 Site access

2.2 Site security

2.3 Site cleanliness

3. Storage buildings

3.1 Construction standards

3.2 Accommodation and layout

3.3 Loading and receiving bays

3.3.1 Loading bays

3.3.2 Receiving bays

3.4 Goods assembly and quarantine areas

3.4.1 Goods assembly areas

3.4.2 Holding area for incoming goods

3.4.3 Quarantine area

3.5 Environmental control of ancillary areas

3.6 Building security

3.6.1 General building security

3.6.2 Controlled and hazardous substances areas

3.7 Fire protection

3.7.1 Fire protection equipment

3.7.2 Fire prevention, detection and control procedures

3.8 Building hygiene

3.8.1 Building cleanliness

3.8.2 Pest control

3.9 Power supply

3.9.1 Uninterrupted power supply

3.9.2 Power failure contingency plan

3.10 Building maintenance

4. Temperature-controlled storage

4.1 Normative references

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

4.5.1 Temperature control

4.5.2 Temperature monitoring

4.5.3 Humidity control

4.5.4 Humidity monitoring

4.6 Alarm systems

4.6.1 Temperature alarms

4.6.2 Humidity alarms

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. Materials handling

5.1 Materials handling equipment

6. Transport and delivery

6.1 Normative references

6.2 Product stability profiles

6.3 Transport route profiling and qualification

6.4 Temperature-controlled transport

6.4.1 Air and sea 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 Shipping containers

6.8.1 Container selection generally

6.8.2 Uninsulated containers

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. Labelling

7.1 Normative references

7.2 Labelling

7.2.1 Labelling generally

7.2.2 Labelling air-freighted shipments

8. Stock management

8.1 Stock control systems

8.1.1 General stock control systems and procedures

8.1.2 Stock control procedures for controlled and hazardous TTSPPs

8.2 Incoming goods

8.2.1 Product arrival checks

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

8.5.1 Suspect products

8.6 Product return, recall, withdrawal and disposal procedures

8.6.1 Return procedures

8.6.2 Recall procedures

8.6.3 Disposal procedures

8.7 Traceability or stock tracking

9. General procedures and record-keeping

9.1 Emergencies and contingency planning

9.2 General record-keeping

9.2.1 Record-keeping

9.2.2 Content of records

9.2.3 Record review and retention

9.3 Temperature and humidity records

9.3.1 Temperature records

9.3.2 Humidity records

10. Environmental management

10.1 Normative references

10.2 Environmental management of refrigeration equipment

11. Quality management

11.1 Normative references

11.2 Organizational structure

11.3 Quality systems

11.3.1 Quality system

11.3.2 Self inspections

11.3.3 Contractors subject to service level agreements

11.4 Management of documents and standard operating procedures

11.4.1 Standard operating procedures

11.5 Document control

12. Personnel/training

12.1 Training

12.1.1 General training

12.1.2 Specialist training

Key references

Further reading

Task force membership

Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products - Annex 9

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