Bioequivalence and Bioavailability Forum • QA Audit Procedure

QA Audit Procedure [GxP / QC / QA]

posted by Ohlbe – France, 2011-01-20 21:26 (5626 d 15:42 ago) – Posting: # 6463
Views: 28,695

Dear all,

Several comments:

First, let's not mix quality control of the data and quality assurance. Helmut, you mentioned a 100 % QA review of the data: I would say a 100 % QC is needed, but not necessarily a 100 % review by QA ! I am not aware of any specific percentage of data to be reviewed by QA.
There are several aspects to QA. One is study-related: that can be in-process audit of critical steps in a given study, and of course checking the report against raw data, or consistency of the raw data. Another aspect is system-based and study-independent (though you will probably pick a study as an example): that will be periodic audits of critical points (once again investigational product dispensing or dosing, sample processing...). These audits will be part of an annual quality audit plan aiming to check that the system works, that SOPs are followed, and to propose possible improvements to the system.

The combination of system-based audits and trial-based audits helps to check the reliability of the data and to (hopefully) increase the confidence in the system and its reliability.

Regards
Ohlbe

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Regards
Ohlbe

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 ProcedureOhlbe 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 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