[Manufacture of DNA chips in a laboratory for internal use: legislation and quality assurance].
Manufacturing and using DNA chips in a laboratory, while respecting legality and good practices, require a review of the regulatory framework and relevant documentation for implementing a quality assurance system. Using DNA chips, either as a research tool, or as an in vitro diagnostic medical device, does not come within the same regulations: none in the first case, and european directive 98/79/CE in the second one. It is the same for research practice, for which the law to be enforced has been primarily conditioned to ethics, while carrying out medical analyses has been framed in France by the GBEA. The regulatory approach laid down in the GBEA is a first step for implementing a quality assurance system, but this must be extended to the manufacturing process of DNA chips. International standards (ISO 9001: 2000, ISO/IEC 15189...) provide documentation to meet this last requirement, but also enable one to carry on the quality approach up to the certification of the laboratory or its accreditation.
Jézéquel
P
P
Départment de biologie oncologique, CRLCC René Gauducheau, boulevard Monod, 44805 Saint Herblain.
Pichon
J
J
Magrangeas
F
F
Minvielle
S
S
Millour
M
M
Ricolleau
G
G
Malvaux
S
S
D015510:Clinical Medicine; D005602:France; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards*; D020411:Oligonucleotide Array Sequence Analysis; D011786:Quality Control