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Description of 19/30366132 DC 2019This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. This document describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines. This document is applicable to all organizations performing biobanking activities with mammalian cell lines used for research and development. Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document. This document does not apply to biological material intended for therapeutic use. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
About BSIBSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses. |
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