AABB accreditation
What is the AABB?
AABB is the global leader in standards development, accreditation and
implementation of quality systems in transfusion medicine and cellular treatments.
Human Tissue Authority (HTA)
What is the HTA?
The HTA was created by the UK Parliament as non-departmental public body of the Department of Health,
overseen by an Authority of lay and professional members appointed by the Government
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Held since 2006 – the very first cord blood bank to receive an HTA licence!
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Regular inspections
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Standards met for: procurement, testing, processing, storage, distribution, import of samples, export of samples
British Standards Institution (BSI)
What is the BSI?
BSI is the business standards company that helps organisations all over the world make excellence a habit.
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Held since 2010
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Certified for operating a Quality Management System ISO 9001:2015
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Covers procurement, storage, testing, processing, import, export, distribution and disposal of stem cells
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Certified across cord blood, cord tissue and dental pulp
Medicines and Healthcare products Regulatory Agency
What is the MHRA?
The Medicines and Healthcare products Regulatory Agency regulates medicines,
medical devices and blood components for transfusion in the UK.
Federal Office of Public Health (OFSP)
Who are the OFSP?
As part of the Federal Department of Home Affairs, the Federal Office of Public Health (FOPH)
is responsible for public health in Switzerland.
Good Distribution Practice for Medicinal Products (GDP)
What is the GDP?
Good distribution practice (GDP) is the standard that a medicines distributor must meet to ensure the quality and integrity of medicinal products for human use.
Medicinal products for human use must be:
- Stored in the right conditions at all times, including during transportation
- Meet the requirements of the Guidelines on Good Distribution Practice of Medicinal Products for Huma Use (2013/C 343/01) of the European Commission
- Meet the requirements of the European GMP Part II (Basic Requirements for Active Substances used as Starting Materials) and GMP Part IV
Swissmedic
What is Swissmedic?
Swissmedic is the Swiss authority for the licensing and monitoring of cell products.
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Since 2013
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Regular audits
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Authorised storage facilities owned in Switzerland
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Standards met for import, export, processing, testing and long-term cryopreservation of stem cell samples
British Standards Institution Member
Who are BSI?
Established in 1901, BSI were the world’s first National Standards Body. Today, they have 90 offices in 193 countries, helping 84,000 organisations make excellence a habit.
Cyber Essentials
What is Cyber Essentials?
Cyber Essentials is a Government-backed, industry supported scheme independently verified by a qualified assessor. The scheme focuses on the following five key areas: