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Risk-based assessment applied to QA GLP audits. How to fulfill regulatory requirements while making the best use of our common sense, knowledge, talents, and resources?
2008
Annali dell'Istituto Superiore di Sanità
For ages the standard plan of internal good laboratory practice (GLP) audits has been designed according to the study critical phases concept. A decade ago the concept of facility-based and processbased audits was adopted, mostly under the influence of short-term and in vitro study design. For unclear reasons, the quarterly inspection scheme has been the prevailing rule. Nowadays, the emerging concept of risk management reaches the field of GLP. In this context, the following items are
pmid:19352000
fatcat:yhvhtgauofbdnasix4kkyetbfe