Bioequivalence and Bioavailability Forum • QA Audit Procedure

QA Audit Procedure [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2011-01-20 13:05 (5223 d 13:39 ago) – Posting: # 6453
Views: 24,830

Dear Swapnil!

❝ Most of Quality Assurance departments used to claim that 20% raw data […] will be audited during course of conduct of the study.

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

No. I don’t think that it makes sense to leave 80% unaudited. IMHO not less than 100% should be audited.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

QA Audit Procedure swapnil.kuche 2011-01-20 06:47
- QA Audit ProcedureHelmut 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

Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
74 visitors (0 registered, 74 guests [including 8 identified bots]).
Forum time: 03:44 CEST (Europe/Vienna)

We should not speak so that it is possible
for the audience to understand us,
but so that it is impossible
for them to misunderstand us. Quintilian

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz