Quality System ISO-GMP

The Skin Bank RER works according to International Standard ISO 9001: 2000 and the approval of Regional Council for authorization and accreditation of its activities (n. 327, 23/02/2004). The management of documents describes the responsibilities about procedure of preparation, review, approval, updating and distribution.

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Certification and Authorization

To guarantee the quality standards applied, the Skin Bank ERR has obtained the following certifications:

1. Certification ISO 9001/2000 (institution that has certified is Bureau Veritas.)
2. Certification CNT 2005
3. Certification CNT 2007
4. Certification CNT 2010
5. Certification CNT 2014
6. Certification CNT 2018
7. Certification CNT 2023

Personnel, Responsibility and Training

The staff of biomedical laboratory technicians works within Cell Factory for the specific activities of the Skin Bank ERR. It is technical personnel afferent to Transfusion Center that works for the common platform of cryobank as well as for the activities of Transfusion Center and it is shared for the processing of cells and tissues.
The staff of biomedical laboratory technicians is adequately trained as defined by Guidelines of National Trasplant Center (September 2016) through an appropriate training program and it is QUALIFIED for the activities of Skin Bank. In addition, it is regularly checked for the maintenance of competences.

Regulations

Guidelines for Harvesting, processing and distributing tissue for transplantation 9/2016

1. DIRECTIVE 2004/23/EC of the European Parliament and of the Council of 31 March 2004.
   It defines quality of standards and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells
2. DIRECTIVE 2006/17/EC of the Council of 08 February 2006 that implements the Directive 2004/23/CE of the European Parliament and of the Council.
   It is related to specific technical requirements for the donation, procurement and control of tissue and cells.
3. DIRECTIVE 2000/86/EC of the Council of 24 October 2006 that implements the directive 2004/23/CE of the European Parliament and the Council.
   It defines the requirements of traceability, the notification of adverse events and specific technical requirements for coding, processing, storage and distribution of human tissues and cells.

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