Certifications - Accreditations - Laboratory Controls
The 1st Licensed Cord Blood bank in Greece!
OMNIGEN SA completed all necessary steps to become the first Private Cod Blood Bank in Greece licensed from Greek State through the Ministry of Health (C2c/31238 OGG Β’ 2339/15.06.2020).
The 1st bank approved by EOM
(National Transplant Organization) for tissue cryopreservation.
The 1st recognized biobank in Greece
by the European body for the recognition of Tissue and Cell Banks (EU TE Code GR012775)
Certificates of Laboratory Compliance according to GMP - GLP
According to the Greek legislation of March 24, 2008 (OGG 51/2008) and from 27 June 2011 (OGG 150/2011) and applying the 2004/23/EK European Directive , all cord blood banks must operate according to the procedures and criteria of GMP (Good Manufacturing Practice). Following the above, Omnigen SA has followed every procedure described in the presidential decree.
Omnigen SA εis accredited by the Lloyd’s Register Quality Assurance according to BS EN ISO 9001:2008 International Quality Management Standard. The certification applies to the isolation and cryopreservation of human umbilical cord blood stem cells. The quality system covers the entire range of laboratory activities, and all corporate organizational processes.
Hellenic Accreditation System (ESYD) - No. 560
Also our laboratories are fully consistent with the procedures dictated by the Hellenic Accreditation System (ESYD) , according to the international standard ELOT EN ISO / IEC 17025: 2005. Accreditation refers to laboratory tests carried out in cord blood samples.. (See relative document)
Omnigen SA in accordance with the above certification and accreditation standards, undergoes audits at regular intervals. As a result, all our services are governed by strict criteria and high quality levels. The Quality Control and Management System that is in place is fully harmonized with the specifications set by the International Organizations FACT (Foundation for the Accreditation of Cellular Therapy), the European Organization for the Inspection of Transplant Units JACIE (Joint Accreditation Committee ISCT-EBMT), the European Directives, as well as the Greek legislation (OGG 51Α, 24/03/2008) so as to establish quality and safety standards for the donation, procurement, screening, processing, preservation, storage and distribution of human tissues and cells).
The Quality Control System guarantees perfect and safe operation of the laboratories and the company in general.
CONTINUING STORAGE CLAUSE
In case of termination or dissolution of the company for any reason, objective inability to keep the stem cells pursuant to current contract sor in general temporary or permanent cessation of its operation and in accordance with Law. 3984/2011 and the Ministerial Decision (OGG 1005B'/2017), Omnigen SA undertakes the obligation to transfer the stem cells to another legally operating and licensed Cord Blood Bank or tissue and cell bank in any country of the European Union for further storage of the cryopreserved samples. Omnigen SA has signed an interconnection contract with such an eligible company for stem cell storage continuation and has informed the relevant ministry.
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