Harmonization criteria for inspection procedures. Italian Group for Quality Assurance in Research
Di Prospero, P.
Annali Dell'istituto Superiore di Sanita 38(1): 35-39
2002
ISSN/ISBN: 0021-2571 PMID: 12122892 Document Number: 545549
In order to achieve higher levels of harmonisation for the application of the principles of good laboratory practice (GLP), the monitoring Authority has set up for the inspectors some guidelines to conduct inspections, as approved by the National co-ordination committee. The extension of these guidelines should allow for an improved application of the GLP principles taking into account actual situations detected during inspections carried out over the past years. In this respect a great number of observations formulated by the inspectors after inspecting several test facilities have been examined without revealing laboratories' and inspectors' identities. In addition to this, the observations made by the inspectors during the annual training course at the Istituto Superiore di Sanità in 2000 have been carefully considered.