Bioequivalence and Bioavailability Forum

....got a wicked idea [Bioanalytics]

posted by ElMaestro  – Denmark, 2015-02-14 00:18 (3792 d 17:17 ago) – Posting: # 14422
Views: 11,811

Hey........thinking loud here: To do GLP you are responsible for your subcontractors. You can be nailed -and nailed badly!- for not having an audit programe in place for them, even if the OECD guideline is not overly clear about vendor oversight. So, how would EDQM react if you tell them you are going to audit them? It would be a perfectly reasonable routine activity for any company buying a standard from them.
Probably such an audit might shed some very relevant light onto why products produced by EDQM are of unknown quality.

I'll be happy to do it on behalf of a client

Complete thread:

• Reference standards janmacek 2015-02-13 10:57 [Bioanalytics] 
  • Reference standards ElMaestro 2015-02-13 11:51
    • OECD GLP Helmut 2015-02-13 14:13
    • Reference standards Ionsource 2015-02-16 08:04
  • Reference standards Ohlbe 2015-02-13 15:49
    • Reference standards nobody 2015-02-13 19:22
      • Reference standards ElMaestro 2015-02-13 23:00
        • ....got a wicked ideaElMaestro 2015-02-13 23:18
          • ....got a wicked idea nobody 2015-02-14 12:49
    • Reference standards janmacek 2015-02-16 12:59
      • Reference standards janmacek 2015-07-15 09:28
        • "solved" ??? ElMaestro 2015-07-15 10:35