GLP or GCP for bioanalysis? [GxP / QC / QA]

posted by ElMaestro  – Belgium?, 2019-01-20 12:54 (678 d 16:17 ago) – Posting: # 19789
Views: 3,885

Dear nobody,

here I think you are going astray.

it is true the OECD GLP guidance was developed for nonclin./tox studies and this is stated in the preamble section of the document, but there is nothing, not one single paragraph anywhere in Eudralex or any other collection of legal or regulatory documents, which precludes regulators from applying the same standard (or another) in any field.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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