Bioequivalence and Bioavailability Forum

Hi ElMaestro!

❝ I would very much welcome some opinions both from those who favor GLP and from those who favour ISO 17025.

Just my experience with the predecessor EN 45001: In the CRO I worked for we discussed the pros & cons in the late 1980s. We considered EN 45001 too inflexible because you have to get an accreditation for every new analytical method (and modifications of ‘old’ ones as well). Leaving the monetary aspects aside contrary to GLP it is a time consuming procedure (filling the application with an accreditation body, wait for the assessment, ).
No qualified opinion about ISO 17025 (duno any accredited lab).

P.S.: We got our first GLP-certification in 1992…