In Norway we have a new law on medical applications of biotechnology,
where there is opportunity to regulate artificial fertilization,
preimplantation diagnostics, pre- and postnatal genetic testing and gene
therapy.
We are currently discussing the criteria for allowing a lab to do genetic
tests, and for allowing specific tests.
One may require the lab to be accredited, by which their way of performing
specific procedures is quality controlled by an external body. By this
procedure they have to do tests in a specific way over long periods.
An alternative, perhaps better suited for research labs and quickly
developing procedures, one may require the lab to get a GLP (Good lab.
practise) certificate.
In both cases an external body will irregularly visit the lab, check the
records and the way work is done.
What is the experience in other countries, have quality controls been
enforced in this way anywhere? I think some Dutch and British labs have
been certified. It would be interesting to hear from these (or be pointed
towards them).
Ola
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Ola Myklebost Email ola.myklebost at labmed.uio.no
Dept of Tumor Biology
Inst for Cancer Research Tel +47-2293-4299
The Norwegian Radium Hospital Fax +47-2252-2421
N-0310 OSLO, Norway
WWW presentation: http://www.med.uio.no/dnr/Inst/TumBiol/Ola/Ola.html
