Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.6.2. DISTRIBUTION

1. When the activities for which the accreditation, designation, authorisation, licensing is sought include distribution of tissues and cells, the authorised TE procedures must comply with the following criteria:

a)   Critical transport conditions, such as temperature and time limit must be defined to maintain the required tissue and cell properties.

b)   The container/package must be secure and ensure that the tissue and cells are maintained in the specified conditions. All containers and packages need to be validated as fit for purpose.

c)   Where distribution is carried out by a contracted third party, a documented agreement must be in place to ensure that the required conditions are maintained.[1]

2. The choice of transport mode is made according to general regulations governing transportation.  The transportation of tissues is carried out following a validated procedure according to the safety and preservation criteria for each tissue type.  These conditions are reflected in the tissue specific GTPs.

3. If tissue to be distributed requires specific environmental conditions other than ambient temperature, the capability of the transport container to maintain the required environmental conditions should be demonstrated and documented in a validation study.  The length of time that these conditions can be maintained by the transport container, assuming normal handling, should also be determined and documented.

4. The place, date and time of departure and arrival, and the identity of the person receiving the tissues should be recorded and kept in the TE or ORHA.

5. If the transport is sub-contracted, a written agreement must be signed between the transporter and the TE which describes what should happen when tissue is damaged or lost during transportation.

6. Any transportation must be accompanied by a transport document that will be attached to the dossier.



[1] Commission Directive 2006/86/EC (Annex II)

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