Bioequivalence and Bioavailability Forum • QA Audit Procedure

QA Audit Procedure [GxP / QC / QA]

posted by ElMaestro – Denmark, 2011-01-20 14:02 (5626 d 16:35 ago) – Posting: # 6454
Views: 28,501

Dear Swapnil,

❝ 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

❝ 1. Do you feel it's ideal procedure to be followed?

Your 20% is not uncommon. Whether or not it is ideal depends on a lot of factors, incl. previous history of noncompliance. Let's say you start out with a much higher percentage than 20 in a young organisation but your qualified auditors don't ever find anything = a mature QMS and you can probably argue the percetange to go down. If on the other hand your auditors ID areas with noncompliance then these can with good argumentation be subject to more intensive audit than others. Along the same lines, if for example nobody left the bioanalytical dept. for six years but 30% of the study nurses in the clin. dept. quit last year then you have a reason for paying closer attention to that.
It sounds a little dumb but I think you should audit to the extent necessary, whether it be 1% or 99%. How to find out which percentage is right for you is a science in itself (risk analyses are popular at the moment; greedy course organisers will be happy to skin you alive).

Best regards,
EM.

—
Pass or fail!
ElMaestro

Complete thread:

QA Audit Procedure swapnil.kuche 2011-01-20 06:47
- QA Audit Procedure Helmut 2011-01-20 12:05
- QA Audit ProcedureElMaestro 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