[The Italian inspection system for good laboratory practice: structure and updates].
The Italian inspecting system for compliance with the good laboratory practice (GLP) principles is fully operative since late 1996. Over these past years documents have been issued and specific guidelines have been worked out to properly perform the activities prescribed. This preparatory work has allowed the Italian system to harmonize with those of the other member states of the European Union. In the frame of other international activities, the Italian Inspectorate has participated in the mutual joint visits programme set up by OECD. Much effort has been invested to pinpoint differences in the approaches followed by the various Italian inspecting teams when inspecting test facilities. From this standpoint, the priority was the attainment of reliable information as well as of solutions that would allow the harmonization of the conduct of GLP inspections. It cannot be overlooked, in fact, that there are 24 inspectors, to whom a substantial number of experts has to be added.
m.capasso@sanita.it
Monica
M
Capasso
D019411:Clinical Laboratory Techniques / Q000592:standards*; D005062:European Union; D006077:Government Agencies / Q000331:legislation & jurisprudence / Q000458:organization & administration; D019983:Guideline Adherence / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D017408:Guidelines as Topic; D007391:International Cooperation; D007558:Italy; D007880:Legislation, Drug; D007881:Legislation, Food; D008330:Management Audit / Q000458:organization & administration; D012106:Research / Q000331:legislation & jurisprudence / Q000592:standards*; D012107:Research Design