Bioequivalence and Bioavailability Forum

QC # QA [GxP / QC / QA]

posted by joy_fm – Indonesia, 2014-01-16 15:55 (4535 d 05:36 ago) – Posting: # 12182
Views: 25,893

Dear riteshsrmc, Mahesh M, ElMaestro
thank you for the explanation. Very helpful

But, I'm still confused by this statement in a previous post from Ohlbe

❝ and of course checking the report against raw data, or consistency of the raw data…

If QC has checked 100% raw data, why QA should check again?
and how to ensure consistency of the raw data, if QA do random check only as an external auditor do?
Because in OECD, only describes QA program and not about the QC Program


Best regards
Joy_fm

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Edit: Standard quotes restored, post linked. [Helmut]

Complete thread:

• QA Audit Procedure swapnil.kuche 2011-01-20 06:47 
  • QA Audit Procedure Helmut 2011-01-20 12:05
  • QA Audit Procedure ElMaestro 2011-01-20 13:02
    • QA Audit Procedure Helmut 2011-01-20 14:13
      • QA Audit Procedure Ohlbe 2011-01-20 20:26
        • QC # QA Helmut 2011-01-21 04:23
          • QC # QA swapnil.kuche 2011-01-21 05:32
          • QC # QA ElMaestro 2011-01-21 13:39
            • QC # QA Ohlbe 2011-01-23 15:18
              • ISO17025 is King ElMaestro 2011-01-25 13:15
              • QC # QA joy_fm 2014-01-15 07:55
                • QC # QA riteshsrmc 2014-01-16 12:55
                  • QC # QA Mahesh M 2014-01-16 13:30
                • QC # QA ElMaestro 2014-01-16 13:35
                  • QC # QAjoy_fm 2014-01-16 14:55
                    • QC # QA Mahesh M 2014-01-17 12:01
                      • QC # QA joy_fm 2014-01-17 13:42
                        • Waste of time Helmut 2014-01-17 14:16
                          • QC # QA joy_fm 2014-01-20 07:38
                      • QC # QA Ohlbe 2014-01-17 15:27
          • QC According to ICH E3 mittyri 2014-01-20 14:29
            • QC According to ICH E3 Helmut 2014-01-20 15:20
              • BE Report: Recommendations to the structure mittyri 2014-01-22 18:44
                • BE creative! Helmut 2014-01-22 20:53