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The Italian inspection system for good laboratory practice: structure and updates

Annali dell'Istituto superiore di sanità, 2002, Vol.38 (1), p.15-18 [Peer Reviewed Journal]

ISSN: 0021-2571 ;PMID: 12122887

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Title:
The Italian inspection system for good laboratory practice: structure and updates
Author: Capasso, Monica
Subjects: Clinical Laboratory Techniques - standards ; European Union ; Government Agencies - legislation & jurisprudence ; Government Agencies - organization & administration ; Guideline Adherence - legislation & jurisprudence ; Guideline Adherence - organization & administration ; Guidelines as Topic ; International Cooperation ; Italy ; Legislation, Drug ; Legislation, Food ; Management Audit - organization & administration ; Research - legislation & jurisprudence ; Research - standards ; Research Design
Is Part Of: Annali dell'Istituto superiore di sanità, 2002, Vol.38 (1), p.15-18
Description: 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.
Publisher: Italy
Language: Italian
Identifier: ISSN: 0021-2571
PMID: 12122887
Source: MEDLINE
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The Italian inspection system for good laboratory practice: structure and updates

ISSN: 0021-2571 ;PMID: 12122887

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