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Medicines & Healthcare products Regulatory Agency
The National Institute for Biological Standards and Control

Confidence in biological medicines

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  • Quality and governance

Quality and governance

The MHRA Science Campus has a robust well embedded framework of processes, procedures and practices that set out Governance and Quality Management Systems structures which underpin all aspects of our work. This enables us to maintain our legal governance requirements, Quality Management Accreditation and Certification statuses, and comply with the Health and Safety Executive (HSE) regulationsfor all NIBSC activities carried out at the MHRA Science Campus.

Details can be accessed in the Medicines and Healthcare products Regulatory Agency (MHRA) Quality Management Systems Statement of Compliance.

Quality Management System 

Our comprehensive Quality Management Systems are embedded within our operating structures, activities and culture and ensures we can provide our customers and stakeholders with the level of service and high-quality products they expect from us.  Our customers can be assured that our Quality Management System has been externally assessed to international standards. 

Certification and Accreditation

  • ISO/IEC 17025:2017 accreditation for defined testing activities related to our batch release of biological medicines under UK law.
  • ISO 9001:2015 certification for the provision of biological reference materials and standards. Management of reagents for research.
  • Human Tissue Authority (HTA) research licences for the storage and use of human tissue for a listed schedule purpose.
  • HTA Human Application Licence held by UK Stem Cell Bank for the storage, procurement, processing, testing and distribution of human tissue for a listed schedule purpose

In line with this policy we aim to maintain our external certification and accreditation for our standards and control work (ISO 9001, ISO 17025), extending the scope as appropriate to cover new tests and areas of work, and ensuring that our research governance framework is robust and fit for purpose.

 
 
 
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