Model requirements v2b - WHO

1 WHO working draft v2b. For public comments. DO NOT circulate. 1 of 42 11 May 2010 1 2 3 4 5 Model requirements for the storage and 6 transport of time and temperature sensitive 7 pharmaceutical products 8 9 10 Version 2b 11 12 13 14 15 16 SEND YOUR COMMENTS TO 17 Dr mit Karto lu by email 18 or 19 by fax +41 22 791 4384 20 21 22 23 24 25 26 27 Revision history: 28 Version 1: Issued 29 Version 1b: Issued 30 Version 2: Issued 31 Version 2a: Issued 32 Version 2b: Issued 33 34 WHO working draft v2b. For public comments. DO NOT circulate.

2 2 of 42 11 May 2010 Contents 1 2 3 Introduction ..8 4 Key to conventions 5 1. 6 Port handling and customs clearance ..9 7 Port of entry ..9 8 Offloading ..9 9 Temporary storage at port of entry ..9 10 Customs clearance ..9 11 2. Warehousing sites ..9 12 Site 13 Natural hazards ..9 14 Site access ..10 15 Site security ..10 16 Site cleanliness ..10 17 3. Storage buildings ..10 18 Construction standards ..10 19 Accommodation and layout ..10 20 Goods assembly and quarantine 21 Goods assembly areas ..11 22 Quarantine 23 Loading bays.

3 11 24 Loading bays ..11 25 Receiving bays ..11 26 Environmental control of ancillary 27 Building security ..12 28 General building security ..12 29 Controlled and hazardous substances areas ..12 30 Fire protection ..12 31 Fire protection equipment ..12 32 Fire-fighting prevention, detection and control procedures ..12 33 Building cleanliness ..13 34 Building cleanliness ..13 35 Pest 36 Uninterrupted power supply ..13 37 Uninterrupted power 38 Power failure contingency 39 Building maintenance ..14 40 4. Temperature-controlled storage.

4 14 41 WHO working draft v2b. For public comments. DO NOT circulate. 3 of 42 11 May 2010 Normative references ..14 1 Storage capacity of temperature-controlled 2 Temperature-controlled storage ..14 3 Temperature-controlled storage for controlled and hazardous 4 Temperature and humidity control and monitoring in storage ..15 5 Temperature control ..15 6 Temperature monitoring ..16 7 Humidity control ..16 8 Humidity monitoring ..16 9 Alarm systems ..17 10 Temperature alarms ..17 11 Humidity alarms ..17 12 Qualification of temperature-controlled 13 Cleanliness of temperature-controlled stores.

5 18 14 Refrigeration equipment maintenance ..19 15 Calibration and verification of control and monitoring devices ..19 16 Calibration of temperature control and monitoring devices ..19 17 Calibration of humidity control and monitoring devices ..19 18 Alarm equipment verification ..19 19 5. Materials 20 Materials handling equipment ..20 21 6. Transport and 22 Normative references ..20 23 Product stability profiles ..20 24 Transport route profiling and qualification ..20 25 Temperature-controlled transport ..21 26 Air and sea transport.

6 21 27 Temperature-controlled road vehicles operated by common carriers 21 28 Temperature-controlled road vehicles generally ..21 29 Transport of controlled TTSPPs and TTSPPs with high illicit value ..22 30 Temperature and humidity control and monitoring during transit ..22 31 Temperature control in temperature-controlled road vehicles ..22 32 Temperature monitoring in temperature-controlled road vehicles ..22 33 Humidity monitoring in temperature-controlled road 34 Temperature monitoring in passive and active shipping containers ..23 35 Qualification of temperature-controlled road vehicles.

7 23 36 Calibration and verification of transport monitoring devices ..24 37 Calibration of transport temperature control devices ..24 38 Calibration of transport temperature monitoring devices ..24 39 Calibration of transport humidity monitoring devices ..24 40 Verification of transport alarm equipment ..24 41 Shipping containers ..24 42 WHO working draft v2b. For public comments. DO NOT circulate. 4 of 42 11 May 2010 Container selection generally ..24 1 Un-insulated containers ..24 2 Qualification of insulated passive 3 Qualification of active containers.

8 25 4 Shipping container packing ..25 5 Product handling during packing and transport ..26 6 Cleaning road vehicles and transport containers ..26 7 Transport of returned and recalled 8 Transport of returned TTSPPs ..26 9 Transport recalled TTSPPs ..27 10 7. 11 Normative references ..27 12 Labelling ..27 13 Labelling 14 Labelling air-freighted 15 8. Stock management ..27 16 Stock control systems ..27 17 General stock control systems and procedures ..27 18 Stock control procedures for controlled and hazardous TTSPPs ..28 19 Goods incoming.

9 28 20 Product arrival checks ..28 21 Actions following arrival checks ..28 22 Goods outgoing (external deliveries)..29 23 Management of outgoing goods ..29 24 Actions following dispatch ..29 25 Product complaint 26 Product return, recall, withdrawal, and disposal procedures ..30 27 Return procedures ..30 28 Recall 29 Disposal procedures ..30 30 Counterfeit product procedures ..31 31 Counterfeit products ..31 32 Traceability/ stock tracking ..31 33 Traceability ..31 34 9. General procedures and record keeping ..31 35 Emergencies and contingency 36 General record keeping.

10 31 37 Record keeping ..31 38 Content of records ..32 39 Record review and 40 Temperature and humidity records ..32 41 Temperature records ..32 42 WHO working draft v2b. For public comments. DO NOT circulate. 5 of 42 11 May 2010 Humidity 1 10. Environmental management ..33 2 Normative references ..33 3 Environmental management of refrigeration 4 11. Quality management ..33 5 Normative references ..33 6 Organizational structure ..34 7 Quality systems ..34 8 Quality system ..34 9 Self inspections ..34 10 Management of documents and 11 Standard operating procedures (SOPs).