Quality Management


Quality Management

 

Central BioHub GmbH was established in 2017 to provide high-quality human biospecimens to biomedical researchers in a fast, easy and compliant way. Our customers are primarily the diagnostic industry and research institutes; therefore, our processes are subject to legal guidelines as well as uncompromising ethical standards. From the day Central BioHub was founded, defined processes manage all corporate’s processes, interaction with our partners and the confidential processing of customer data. Central BioHub strictly follows international data protection regulations, in particular the EU General Data Protection Regulation (GDPR).

Our Quality Management System

The best quality of all human biological samples and customer satisfaction without compromises are cornerstones of our company. We strive to provide our customers with products and services which meet and even exceed their expectations. For this purpose, Central BioHub has implemented a detailed and transparent quality management system. It sets out a framework defining the entire work processes and enables measurement of our performance. Through regular self-monitoring and external audits, we continuously improve and expand our quality standards.

All partners are contractually committed to complying with our standards. Our suppliers are validated according to a stringent, defined process. Here, both the ethical compliance of the specimen collection and the quality management system are inspected regularly to meet our strict criteria. On-site audits at our partner’s biorepository facilities guarantee superior cryopreservation conditions for all specimens to maintain biomarkers for a long time. Continuous digital audits sustain our world-class standards and communicate any non-conformances immediately with the biospecimen suppliers.

ISO 9001 Certification

DIN EN ISO 9001:2015 sets out the criteria for a coherent and seamlessly working quality management system. It includes a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. All business units operate in accordance with ISO 9001, which guarantees the highest level of safety and quality to match your products and regulated business areas. Central BioHub is continuously working towards certification by a notified body, which will be successfully completed by the end of 2021. The Quality Manual is made available to all employees and can be requested by clients in English and German (link to e-mail).

Ethics

We are committed to international ethical standards for all biospecimens offered on centralbiohub.com, independently of which partner is providing the samples . Central BioHub observes the principles of the Declaration of Helsinki (LINK) and the Declaration of Taipei (LINK) as defined by the World Medical Association. Suppliers of Central BioHub are fully committed to strict compliance with the IRB and Ethics Committee (IEC) and all applicable regulations, guidelines and best practices that meet international policies.

Our ethical requirements for sourcing human biospecimens:

We are committed to international ethical standards for all biospecimens offered on centralbiohub.com, independently of which partner is providing the samples. Central BioHub observes the principles of the Declaration of Helsinki (LINK) and the Declaration of Taipei (LINK) as defined by the World Medical Association. Suppliers of Central BioHub are fully committed to strict compliance with the IRB and Ethics Committee (IEC) and all applicable regulations, guidelines and best practices that meet international policies.

  • Specimens for scientific research offered on centralbiohub.com that originate from dedicated specimens collections or clinical remnants have been collected and approved by an IRB/IEC or comparable ethics committee.
  • For all products obtained from specimen collections for scientific research, an informed consent from the donor is available. The submission of the informed consent form is regularly checked by the Central BioHub compliance department.
  • Clinical remnant samples do not require informed consent from the subject regulating the further use of the specimens (see 45 CFR 46, §46.104 Exempt research, exemption d, 4 LINK). Sample-related data is available anonymised or highly pseudonymised, so that the possibility of inference from specimen data to an identifiable donor is being minimised.

Central BioHub will provide specimen compliance documentation upon request. Reach out to us for more information on the quality management and international regulations by contacting our Compliance department (Link to e-mail).

 
All departments of Central BioHub are working according to a detailed and transparent Quality Management System (QMS) which is in compliance with DIN EN ISO 9001:2015. It includes regular internal audits and on-site inspections at the supplier’s facilities.
Central BioHub is in the process of receiving ISO 9001 certification and expects certification in the coming months.
Central BioHub observes principles of the Declaration of Helsinki, which is setting ethical principles regarding human experimentation (LINK) defined by the World Medical Association. Furthermore, it acts in compliance with the Declaration of Taipei (LINK) which defines applications of health data and biobanks.
  • Specimens derived from dedicated collections and clinical residuals are approved by IRB/IEC or equivalent ethics committee.
  • Specimens derived from dedicated collections were collected with informed consent of the donor.
  • Documentation will be provided upon request.
  • All suppliers are subject to a multi-stage validation process, whereby all required documents are provided. Regular on-site audits at our supplier’s facilities and frequent checking of legal documents ensures compliance with international regulations.
  • Customers are activated after completing a form with self-disclosure and additional research by our Customer Service.
Central BioHub operates with the utmost degree of transparency. The quality manual is made available on request.