Water and its analyses under GLP compliance

摘要

There are no detail descriptions concerning method of water analyses in comments of Good Laboratory Practice Standards for Non-clinical Safety Studies (GLP), Ordinance No. 21 of Ministry of Health and Welfare (MHW) Japan. Standard of Protocol (SOP) concerning detail methods of water supply and its analyses defined by Pharmaceuticals or Medical Devices Agency is required to ensure the level of each water quality parameter is within the acceptable level. We will show the methods such as the site of water sampling, analyses items, each acceptable range of analyses data and the frequency of analyses specified by the SOP in our laboratory under GLP compliance.