kishan_123
☆    

India,
2019-11-06 15:27

Posting: # 20757
Views: 1,324
 

 Reporting of QA [GxP / QC / QA]

Dear Forum,

Greetings.

I would like to know your views on following situation.

If a clinical site have only one PI and there are no other senior person such as Director/Head other than PI. In Such Case QA should report to whom and all the QA SOP should be reviewed & Approved by whom.

Would appreciate your feedback.

Regards,
Kishan
PharmCat
★    

Russia,
2019-11-07 17:18

@ kishan_123
Posting: # 20761
Views: 976
 

 Reporting of QA

Hello!

What quality standards do you implementing?
kishan_123
☆    

India,
2019-11-11 05:01

@ PharmCat
Posting: # 20781
Views: 926
 

 Reporting of QA

» What quality standards do you implementing?

Hello,,

We are implementing Clinical Research (BABE) Quality Standards in one of the Hospital Site.

Kr,
ElMaestro
★★★

Belgium?,
2019-11-11 09:14

@ kishan_123
Posting: # 20782
Views: 904
 

 Reporting of QA

Hi,

» If a clinical site have only one PI and there are no other senior person such as Director/Head other than PI. In Such Case QA should report to whom and all the QA SOP should be reviewed &

It is not uncommon that small sites do not have a classical structure with independent QA.
However, such sites are by the nature of the game usually subcontracted by someone who has the overarching QA task, and who does the auditing and final QA review. Therefore, independence of QA, which is a formally enforced requirement, is assured in such cases. The organised system with site investigator files, trial master files, source pave the way for its relatively easy implementation.

The people doing QA at such sites could as well be called something else, like QC employees.

Le tits now.

Best regards,
ElMaestro
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