Certifications
Since its founding in 2010, bioKryo has continuously improved its processes and obtained a series of accreditations.
The bioKryo-Biobanking network offers the highest standards of storage services in terms of safety, quality, reliability and traceability.
All our processes are designed to maximize sample quality as part of certified quality systems.
bioKryo-Biobanking aims to harmonize all processes and quality systems across the network, providing the same highest quality standards wherever a sample is stored.
Our certifications
As a certified biobank, we have established a quality management system to ensure the highest quality specimens and data, while protecting the donor’s rights, including privacy and confidentiality. Validation of our processes gives stakeholders confidence in data accuracy and quality of your samples.
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ISO 9001:2015
Certification for Biobanking and Bioservices -
GDP - compliant
Good Distribution Practices -
GMP - compliant
Good Manufacturing Practices
bioKryo France
Quality assurance system and certifications
- Certification ISO 9001:2015
- Certification NFS 96-900
- Certification ISO 20387
- Application of good pharmaceutical practices : GMP, GCP, GCLP
- GMO Approval
- Respect of the BPR (Best Practices for Repositories de l’ISBER)
- Periodic checks of the various sample security systems
- Qualification of the equipments (QI/QO)
bioKryo Germany
Quality assurance system and certifications
- German Drug Law Approval
With the establishment of bioKryo in 2010, the local Ministry of Health provides the authorization for storage of cryopreserved samples according to § 20c and § 52a of the German Drug Law. This approval includes the cryostorage of drugs, and is proof of the GMP-compliant service of bioKryo GmbH. - GMO Approval
bioKryo received approval for the storage of genetically modified organisms up to security level S2 from the Ministry of Environment of the Saarland. - ISO 9001:2015
Since 2013, the certification of ISO 9001:2015 for the cryostorage process had been successfully carried out by GZQ “Gesellschaft zur Zertifizierung von Qualitäts- und Umweltmanagement-Systemen mbH”. - AABB accredited
Since 2016, bioKryo was accredited by the AABB standard for their service in storing cord blood for future therapeutic applications.
bioKryo Italy
Quality assurance system and certification
- ISO 9001:2015 certification for both biobank and laboratories
- Good Distribution Practices (GDP) compliant
- Good Manufacturing Practices (GMP) compliant
- National Transplant Center accreditation (on going)
- GMO Approval
- Periodic checks of the various sample security systems
- Qualification of the equipments (QI/QO)