New Draft of Inspection Guideline on Tissue and Cell Procurement

GMP News
14 May 2008
 

New Draft of Inspection Guideline on Tissue and Cell Procurement

  
In March the 4th Draft of Edition II of the "Guidelines for the Inspection of Tissue and Cell Procurement and Tissue Establishments" was published within the framework of the EUSTITE (European Standards and Training in the Inspection of Tissue Establishment) project. In the EUSTITE Project, 11 national organisations from 10 member states as well as the WHO are represented. 10 of the national organisations are their countries' official registration authorities for tissue and cell procurement establishments.

This guideline is intended to provide guidance to member states that establish the corresponding regulations for the first time. To those member states that have already implemented the respective directives, it is meant to be helpful in the process of standardisation. It was drafted in compliance with the Directives 2004/23/EC, 2006/17/EC and 2006/86/EC, which deal with the quality and safety of human tissues and cells procured for transplants or related purposes. These include:

  • the inspection and accreditation, designation, authorisation and licensing of tissue establishments
  • the authorisation of procedures for tissue and cell procurement
  • the authorisation of processing tissues and cells and,
  • the regulation of import and export of tissues and cells.

The guideline lays down requirements on subjects like qualification and training of inspectors (chapter 2) and on the types of inspection (chapter 4). It gives clues for activities in the inspection preparation phase, during and after an inspection (chapter 5).

Furthermore, the annexes address inspections in the field of donor recruitment and testing, but also processing, storage and transport of the donation. They also include templates for the necessary documents, like inspection reports, tissue, establishment and process dossier.

Further information can be found at:
http://www.eustite.org/index.php?option=com_content&task=view&id=19&Itemid=69

Author:
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)
 

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