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

posted by ElMaestro  – Belgium?, 2019-01-20 11:42 (646 d 07:57 ago) – Posting: # 19787
Views: 4,149

Hi all,

more confusion at my end, it is something very basic.

EU guideline on BE: "The bioanalytical part of bioequivalence trials should be performed in accordance with the principles of Good Laboratory Practice (GLP)"

EU guideline on method validation: "The validation of bioanalytical methods and the analysis of study samples for clinical trials in humans should be performed following the principles of Good Clinical Practice (GCP)"

So, which guideline(s) must a CRO follow for sample analysis for EU studies: GLP or GCP or both?
Does validation "only" need to comply with GCP and if yes, can you give a practical example of the real difference?

If you are saying both GLP and GCP need to be observed in some cases then I may have a natural question about the meaning of the term "principal investigator"....:-)

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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