Bioequivalence and Bioavailability Forum • QA Audit Procedure

QA Audit Procedure [GxP / QC / QA]

posted by swapnil.kuche – 2011-01-20 07:47 (5626 d 10:41 ago) – Posting: # 6452
Views: 30,385
(edited on 2011-01-20 11:20)

Dear All,

Most of Quality Assurance departments used to claim that 20% raw data (Inprocess & Retrospective) and final bioequivalence report will be audited during course of conduct of the study.
My question is

Do you feel it's ideal procedure to be followed?
If yes. Do you have any reference regulatory guidance or any literature for the same supporting above mentioned statement?

Thanks
Swapnil

Complete thread:

QA Audit Procedureswapnil.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 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