Bioequivalence and Bioavailability Forum • GLP or GCP for bioanalysis?

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

posted by ElMaestro – Denmark, 2019-01-20 14:54 (1528 d 01:37 ago) – Posting: # 19789
Views: 5,957

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.

—
Pass or fail!
ElMaestro

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