Bioequivalence and Bioavailability Forum • QC # QA

QC # QA [GxP / QC / QA]

posted by Ohlbe – France, 2014-01-17 16:27 (4530 d 01:21 ago) – Posting: # 12189
Views: 25,971

Dear Manesh,

❝ Yes you are right because QA work as independent body means QA not repored to laboratory manager or analysist but QC reported to laboratory manager/ Scientest.

Sorry but I totally disagree with this statement. Actually I would put it the other way round:

QC results can be discussed with whoever made a mistake, so that the mistake gets corrected, but do not necessarily need to be reported to management, unless there are systematic errors requiring corrective and preventative action;
QA audit results have to be reported to management. See OECD GLP §2.2.e:

The responsibilities of the quality assurance personnel include, but are not limited to, the following functions. They should: […] promptly report any inspection results in writing to management and to the study director […].

("Inspection" in this case should be understood as QA audit, not regulatory inspection), as shown by § 2.2.c).

—
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 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 # QAOhlbe 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