BS ISO 21973:2020
$142.49
Biotechnology. General requirements for transportation of cells for therapeutic use
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 28 |
This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation.
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.
This document does not apply to transportation of cells within one facility.
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.
This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 6 | Foreword |
| 7 | Introduction |
| 8 | 1 Scope 2 Normative references 3 Terms and definitions |
| 11 | 4 General concepts |
| 12 | 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 |
| 13 | 5.2.3 Capability of the cell transportation service provider and its external service provider(s) |
| 16 | 5.3 Risk management, verification and validation 5.3.1 Risk management |
| 17 | 5.3.2 Verification and validation 6 Best practices for shipping container and labelling 6.1 General |
| 18 | 6.2 Shipping container 6.2.1 Shipping container systems 6.2.2 Shipping container requirements |
| 19 | 6.3 Labelling of the shipping container 6.3.1 Information to be labelled |
| 20 | 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 |
| 21 | 7.1.4 Inspection at the time of delivery 7.2 Traceability |
| 22 | 7.3 System to handle exceptional operations 7.3.1 Emergency handling 7.3.2 Management in case of an incident |
| 23 | 8 Organization 8.1 General 8.2 Personnel training 8.2.1 General 8.2.2 Training plans |
| 24 | 8.2.3 Training records 8.3 Quality management system (QMS) considerations |
| 25 | 9 Storage facility 9.1 General 9.2 Storage facility considerations 10 Documented information |
| 26 | Bibliography |
