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chidambarajoshi ★ Hyderabad-INDIA, 2007-08-09 11:20 (6901 d 14:50 ago) Posting: # 968 Views: 4,754 |
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Hi, Is there any guideline to be followed if whole facility of BA/BE is shifted from one location to other, Facility include clinical, bioanalysis and statistics? And what measure is need to be taken in such case? Regards Joshi |
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Helmut ★★★   Vienna, Austria, 2007-08-09 21:56 (6901 d 04:15 ago) @ chidambarajoshi Posting: # 969 Views: 4,036 |
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Dear Joshi! ❝ Is there any guideline to be followed if whole facility of BA/BE is shifted from one location to other, Facility include clinical, bioanalysis and statistics?  ❝ And what measure is need to be taken in such case? I would go with common sense: First you should review all your SOPs for necessary changes (e.g., new network architecture, hardware,…). Next, since GLP-certificates and reports of GCP-inspections are always issued for a particular site, they have to be renewed. The same is true for applicable GMP-certificates (e.g., if repackaging of IMPs is performed). A helpful resource is given in TRS 937, Annex 9 (WHO, 2006). — 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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Ohlbe ★★★ France, 2007-08-21 19:39 (6889 d 06:32 ago) @ Helmut Posting: # 999 Views: 3,771 |
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Dear Joshi! As HS I would mention common sense as the primary guideline... If you totally close down your old facility I would suggest you to inform the sponsors of all trials you have performed in the past, giving them your new address + phone/fax number if changed. They need to be able to contact you should they receive questions from some regulatory authority or a notification of an on-site inspection (some EU authorities contact the sponsor first rather than the site). And it's a good opportunity to remind them that you are still in this business and willing to work for them  Regards Ohlbe |
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chidambarajoshi ★ Hyderabad-INDIA, 2007-12-22 13:26 (6766 d 11:45 ago) @ Helmut Posting: # 1418 Views: 3,580 |
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Dear All, Thanks for reply, And we did it accordingly. We have intimated to sponsers also Regards, joshi  — Best Regards Joshi |
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suba_vivek ☆ 2007-11-06 05:45 (6812 d 19:26 ago) @ chidambarajoshi Posting: # 1286 Views: 3,690 |
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Dear Mr. Joshi, In case of change in facility, the important things that you should consider is the changes in SOPs, instrument/ equipment requalifications. All changes should be taken through a proper change control procedure and it should all be documented. Regards, Subashini V. Edit: Full quote removed. Please see this post! [Helmut] |
Ing. Helmut Schütz