Bioequivalence and Bioavailability Forum • QC According to ICH E3

QC According to ICH E3 [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2014-01-20 16:20 (4536 d 15:44 ago) – Posting: # 12206
Views: 25,905

Hi Miityri,

❝ Could you explain your practice: have you used to include in this chapter QC data?

In my reports I use to give in this section certificates of the clinical laboratory (e.g., attendance in national interlaboratory comparison programmes, ISO 900x, accredited methods) covering parameters measured in pre-/post study exams.
I never referred to the bioanalytical method used for PK there.

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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 # QA joy_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 E3Helmut 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