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kaushik089 ★ India, 2012-05-24 12:35 (5149 d 21:05 ago) Posting: # 8616 Views: 3,730 |
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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. |
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suds4u ☆ India, 2012-05-25 15:47 (5148 d 17:53 ago) @ kaushik089 Posting: # 8617 Views: 3,117 |
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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] |
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ElMaestro ★★★ Denmark, 2012-05-25 21:15 (5148 d 12:26 ago) @ suds4u Posting: # 8618 Views: 3,087 |
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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 |
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kaushik089 ★ India, 2012-05-29 20:27 (5144 d 13:13 ago) @ ElMaestro Posting: # 8629 Views: 3,026 |
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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).  thanks again, kaushik. |
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Helmut ★★★   Vienna, Austria, 2012-05-29 22:28 (5144 d 11:13 ago) @ kaushik089 Posting: # 8630 Views: 3,029 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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kaushik089 ★ India, 2012-05-30 15:26 (5143 d 18:14 ago) @ Helmut Posting: # 8631 Views: 2,964 |
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Thank you so much for that guidance. |
Ing. Helmut Schütz