Bioequivalence and Bioavailability Forum

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

posted by ElMaestro  – Denmark, 2019-01-20 12:42 (2093 d 23:06 ago) – Posting: # 19787
Views: 8,720

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"....

Complete thread:

• GLP or GCP for bioanalysis?ElMaestro 2019-01-20 11:42 [GxP / QC / QA] 
  • GLP or GCP for bioanalysis? nobody 2019-01-20 13:47
    • GLP or GCP for bioanalysis? ElMaestro 2019-01-20 13:54
      • Both, Cap't'n ! Ohlbe 2019-01-20 23:11
        • Both, Cap't'n ! ElMaestro 2019-01-21 09:42
          • Both, Cap't'n ! nobody 2019-01-21 10:25
          • Both, Cap't'n ! Ohlbe 2019-01-21 11:05
            • Both, Cap't'n ! ElMaestro 2019-01-21 11:28
              • Both, Cap't'n ! Ohlbe 2019-01-21 11:51
        • A great idea ElMaestro 2019-01-22 22:39
          • Statements of GCP and GLP compliance Ohlbe 2019-01-23 00:29