Bioequivalence and Bioavailability Forum

QA Audit Procedure [GxP / QC / QA]

posted by Helmut  – Vienna, Austria, 2011-01-20 15:13 (5623 d 09:00 ago) – Posting: # 6455
Views: 28,879

Dear ElMaestro & Swapnil!

❝ It sounds a little dumb but I think you should audit to the extent necessary, whether it be 1% or 99%.

OK.

❝ 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).

Well, Swapnil has asked for raw data audits. I think even more important is checking critical points, which cannot be corrected afterwards:

• Administration
  
• Transfer of plasma after centrifugation (potential mix-up)

IMHO both points should be covered either by a bar-code system or performed following the four-eye principle.

When it comes to data-transfer again it depends… When we switched from manual data-entry (CDSs ⇒ calibration ⇒ analytical results ⇒ biostatistical database) to electronic data flow within a LIMS we evaluated two studies in parallel during validation. We expected less than 1% of transfer errors (mainly transposed digits like 3657.45 instead of 3567.45) but were surprised to find ≈2%. Didn’t affect the studies’ outcome (maybe in the 6^th decimal), but still interesting. Once the data-flow is validated, I think it's sufficient to check whether it was followed according to the SOPs (audit trail, hardcopies, ).
However, if data come from external sources I don’t get the point why the data-import (analytics, lab values ⇒ statistics) should not be checked 100%. Takes about one hour for an average study. I have seen strange things (mostly caused by the nightmare Excel). Data in some (!) cells were formatted as text instead of numbers. The import seemed to work, but set text values to missing (the nice ‘.’ in SAS). Bad luck if you checked only 20%.

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


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 Procedure Helmut 2011-01-20 12:05
  • QA Audit Procedure ElMaestro 2011-01-20 13:02
    • QA Audit ProcedureHelmut 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