kaushik089
★    

India,
2012-05-24 12:35
(5149 d 04:23 ago)

Posting: # 8616
Views: 3,726
 

 system audit query [Regulatives / Guidelines]

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hello all,

My question is, will the US (fda) and DCGI (India) conducts system audits ? If yes will it be a paid audits or not?

thanks in advance,

warm regards,

kaushik.
 
suds4u
☆    

India,
2012-05-25 15:47
(5148 d 01:11 ago)

@ kaushik089
Posting: # 8617
Views: 3,113
 

 system audit query

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Dear Kaushik
USFDA will not do any system audit, its study inspection.
DCGI will do facility inspection initially and follow up inspection if necessary on need basis.
Regards
Suds

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
 
ElMaestro
★★★

Denmark,
2012-05-25 21:15
(5147 d 19:43 ago)

@ suds4u
Posting: # 8618
Views: 3,085
 

 system audit query

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Hi Suds,

❝ USFDA will not do any system audit, its study inspection.


I think it not as black or white as that; GMP-wise FDA's inspections often have character of system inspections while their review of clinical sites and bioanalytical labs are often study-specific.
—
Pass or fail!
ElMaestro
 
kaushik089
★    

India,
2012-05-29 20:27
(5143 d 20:31 ago)

@ ElMaestro
Posting: # 8629
Views: 3,023
 

 system audit query

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Hello all,

first of all thank u so much for the valuable information.

what are the key elements on which USFDA audits shows concerns while conducting system audits (in India).:confused:

thanks again,


kaushik.
 
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2012-05-29 22:28
(5143 d 18:31 ago)

@ kaushik089
Posting: # 8630
Views: 3,026
 

 system audit query

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Dear Kaushik!

Maybe you find FDA’s 2002 Guide to International Inspections and Travel helpful. See esp. Chapter 3 Establishment Inspections.
—
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Helmut Schütz
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kaushik089
★    

India,
2012-05-30 15:26
(5143 d 01:32 ago)

@ Helmut
Posting: # 8631
Views: 2,961
 

 system audit query

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Thank you so much for that guidance.
 
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