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
- the inspection and accreditation, designation,
authorisation and licensing of tissue establishments
- the authorisation of procedures for tissue and cell
- 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:
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)