Bioequivalence and Bioavailability Forum • QC According to ICH E3

QC According to ICH E3 [GxP / QC / QA]

posted by mittyri – Russia, 2014-01-20 15:29 (4534 d 09:46 ago) – Posting: # 12205
Views: 25,902

Dear Helmut & All,

According to the ICH E3 Guideline there could be an Appendix 16.1.10. "Documentation of inter-laboratory standardisation methods and quality assurance procedures if used" in the Clinical Study Report.
In our BEQ reports we include in this chapter only the information about method preparation and validation & QA (if any). The information about QC series is usually included to the chapter PK evaluation of the main report.

Could you explain your practice: have you used to include in this chapter QC data?

—
Kind regards,
Mittyri

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 # QA Ohlbe 2014-01-17 15:27
        
        QC According to ICH E3mittyri 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