This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation.<\/p>\n
Transportation starts from the transfer of the packaged cells by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination.<\/p>\n
This document does not apply to transportation of cells within one facility.<\/p>\n
This document includes the development of a transportation plan including verification and validation, communication between the client and the transportation service provider, and associated documentation.<\/p>\n
This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 4 General concepts <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 5 Cell transportation specification 5.1 General 5.2 Items specified in the cell transportation specification 5.2.1 General 5.2.2 Information reflected in the cell transportation specification <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 5.2.3 Capability of the cell transportation service provider and its external service provider(s) <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.3 Risk management, verification and validation 5.3.1 Risk management <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.3.2 Verification and validation 6 Best practices for shipping container and labelling 6.1 General <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 6.2 Shipping container 6.2.1 Shipping container systems 6.2.2 Shipping container requirements <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 6.3 Labelling of the shipping container 6.3.1 Information to be labelled <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 6.3.2 Physical requirements for the label 6.3.3 Handling of labels 7 Operation 7.1 General operation 7.1.1 General 7.1.2 Preparation of shipment 7.1.3 Transportation <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 7.1.4 Inspection at the time of delivery 7.2 Traceability <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 7.3 System to handle exceptional operations 7.3.1 Emergency handling 7.3.2 Management in case of an incident <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 8 Organization 8.1 General 8.2 Personnel training 8.2.1 General 8.2.2 Training plans <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 8.2.3 Training records 8.3 Quality management system (QMS) considerations <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 9 Storage facility 9.1 General 9.2 Storage facility considerations 10 Documented information <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Biotechnology. General requirements for transportation of cells for therapeutic use<\/b><\/p>\n |