Bioequivalence and Bioavailability Forum • QA Training: SOPs, protocol

QA Training: SOPs, protocol [GxP / QC / QA]

posted by Ohlbe – France, 2008-11-15 14:16 (6428 d 21:42 ago) – Posting: # 2676
Views: 25,596

Dear Vishal,

For the clinical part of the trial and for the PK and stats analyses, according to the ICH GCP guideline, §5.19.1:
The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

For the bioanalytical part of the trial, according to the OECD principles of GLP, §2.2.1.c, responsibilities of QA personnel:
conduct inspections to determine if all studies are conducted in accordance with these Principles of Good Laboratory Practice. Inspections should also determine that study plans and Standard Operating Procedures have been made available to study personnel and are being followed.

QA personnel may not need the same level of "SOP training" that the personnel who will use them, but obviously they have to know what's inside. Same for the protocol, at least if there are specific requirements compared to the standard protocol you use.

Regards
Ohlbe

Complete thread:

QA Training vish14184 2008-11-15 09:35
- QA Training: SOPs, protocolOhlbe 2008-11-15 13:16
  - QA Training: SOPs, protocol chidambarajoshi 2008-11-17 11:08
    - QA Training: SOPs, protocol vish14184 2008-11-18 09:12
      - QA Training: SOPs, protocol mbshankar 2008-11-18 11:31
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-18 12:00
        
        QA Training: SOPs, protocol mbshankar 2008-11-18 12:43
        
        QA Training: SOPs, protocol chiragkhatri 2008-11-19 05:56
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 07:28
        
        QA Training: SOPs, protocol mbshankar 2008-11-19 10:43
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:45
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:47
        
        QA Training: SOPs, protocol mbshankar 2008-11-20 06:46
        
        QA Training: SOPs, protocol vish14184 2008-11-20 09:37
        QA Training: SOPs, protocol chidambarajoshi 2008-11-21 05:43
        
        QA Training: SOPs, protocol mbshankar 2008-11-22 05:09
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-24 11:22
        
        QA Training: SOPs, protocol mbshankar 2008-11-24 12:22
        
        QA Training: SOPs, protocol Ohlbe 2008-11-24 12:41
        QA Training: SOPs, protocol chidambarajoshi 2008-11-24 12:49
        LLOQ / Cmax Helmut 2008-11-24 12:54