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QUALITY
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Certification ISO 9001 :
2000 Biological Resource Center : collection, validation,
preparation, aliquoting, preservation, management and
distribution of documented biological samples.
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Collection and redistribution of biological samples
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For safety
reasons, the Biobanque de Picardie assures in
situ collection of samples. Thus, the quality of stocked
material is guaranteed. Samples are redistributed in accordance
with current French and European legislation.
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Biological samples are conserved in high security straws made
from ionomer resin, which prevents physico-chemical interactions
between the sample and the container. Straws are filled
automatically and given a barcode. They are inviolable and
impossible to falsify.
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Each biological sample is divided into aliquots. If a
collection owner needs to consult or analyse the collection,
only one aliquot needs to be removed and opened, so multiple
analyses can be carried out and information can be continually
collected. |
Biological samples are stored at - 80°C in electric freezers
or at -196°C in liquid nitrogen.
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Quality-assurance procedures
Validation procedures exist for each
collection.
The conservation quality is guaranteed by monitoring, alarm and
rescue systems.
Studies based on straw-conserved material can be performed
either on-site or in an external laboratory. The Biobanque de
Picardie R&D Laboratory is equipped for immunological and
molecular biology techniques.
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TRACEABILITY |
The Biobanque de Picardie uses a computer programme
formatted for 256 000 samples, which can save files and
integrates all the information concerning sample origin,
storage and potential destinations for redistribution. It
can also integrate all of the clinical and biological
information associated with each sample. Sample anonymity is
assured during storage and management.
Written protocols exist for each collection
| Ethical
and legal context |
The Biobanque de Picardie's activities in terms of
transformation, conservation and use of human tissue and
cells fall within articles L1131-4 and L1243-2 of the French
Public Health Code.
The Bioethics Act of July 29th, 1994 in the
French Civil Code makes stipulations on the use of products
and elements from the human body. The Biobanque de Picardie
Association is run in accordance with the following
articles:
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- Article
16-1
of the civil code concerning the
non-patrimoniality of the human body: "The
human body, its elements and products cannot be
subjected to any patrimonial rights".
- Article 16-6 of the civil code concerning
donations: "A person who agrees to participate in
any kind of experimentation on himself or to offer bodily elements
or products cannot receive any kind of remuneration".
- Article 7
of the civil code concerning the non-patentability of
the human body: "Inventions whose
publication
or application would go against "ordre
public" or public morals cannot be patented. Thus,
the human body, its elements and products, as well as
knowledge on the
total or partial structure of a human gene, cannot be patented".
In agreement with the principles for correct tissue
conservation, as applied in biomedical laboratories,
the Association complies with:
- Articles R672-21 to R672-24 of the French
Public Health Code, which transpose the 30th August 1999
Act (Act No 99-741) concerning good practice in the
conservation and use of human tissues and their
derivatives.
The Biobanque de Picardie respects the safety
measures appearing in the 23rd February 2000 Act and
in the 20th April 2000 by-law concerning the transport
and conditioning of human biological material.
Any test or biomedical research involving human
material must also respect the rules of the December
20th 1988 " Huriet Act"
(Articles 1121-1 to 1126-7 of the French Public
Health Code).
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