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cakhatri ★ India, 2012-10-07 13:30 (4597 d 02:30 ago) Posting: # 9328 Views: 7,465 |
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Dear members, Can anyone provide information/ link to UKMHRA or other EU regulatory website, we would like to call UKMHRA or any EU agency for facility inspection w.r.t GCP/GLP compliance. Rgards CK Edit: Category changed. [Helmut] |
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ElMaestro ★★★ Denmark, 2012-10-07 14:50 (4597 d 01:10 ago) @ cakhatri Posting: # 9329 Views: 6,587 |
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Hi cakhatri, Contact details here. But are you really sure you want an inspection when none is strictly required? I'd like to hear the background for your question. It almost sounds like you'd request a system inspection rather than (await?!) a study inspection. Is it solely in order to be able to tell prospective partners that you have been inspected? — Pass or fail! ElMaestro |
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cakhatri ★ India, 2012-10-09 08:57 (4595 d 07:04 ago) @ ElMaestro Posting: # 9346 Views: 6,321 |
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Hi ElMaestro, Thanks for the response and the link. Yes, your assumption is correct. We intend to call for a facility inspection by any major EU regulatory inorder to inform prospective customers about the site being inspected by them Regards Chirag 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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Helmut ★★★   Vienna, Austria, 2012-10-07 15:21 (4597 d 00:40 ago) @ cakhatri Posting: # 9331 Views: 6,600 |
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Hi CK! Click the icon:  (Hint: 4th hit).If BE studies are of concern, no European member state runs a facility inspection program. MHRA has established an accreditation program on a national basis – but only for CROs performing FIM studies. — 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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Dr_Dan ★★ Germany, 2012-10-08 15:07 (4596 d 00:53 ago) @ Helmut Posting: # 9333 Views: 6,594 |
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Dear all I know that no “GCP certificates” for BE-centers are issued by EU RAs, however, some (east or south EU) RAs ask for GCP certificates for studies (study centres) included in the dossier for marketing authorization application although there is no legal base for this. A GCP inspection is study related, focuses on conditions, practices or processes that affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data and is not a system audit (EMEA/INS/GCP/197226/2005). However, to my knowledge there had been some discussions at EMA whether to issue GCP certificates or not but I do not know the outcome. Someone else? Kind regards Dan Edit: Document linked. [Helmut] — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★ Vienna, Austria, 2012-10-08 15:56 (4596 d 00:04 ago) @ Dr_Dan Posting: # 9335 Views: 6,581 |
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Dear Dan! ❝ […] some (east or south EU) RAs ask for GCP certificates for studies (study centres) included in the dossier for marketing authorization application […]. Luckily I did not experience that so far. I faced only – unresolvable (!) – cases in Jordan and Turkey…  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2012-10-08 18:22 (4595 d 21:38 ago) @ Dr_Dan Posting: # 9336 Views: 6,475 |
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Hi Dr_Dan, Greetings from Hamburg, where I hang out today  Shouldn't have let my first officer follow his instinct and the polar star.❝ I know that no “GCP certificates” for BE-centers are issued by EU RAs, however, some (east or south EU) RAs ask for GCP certificates for studies (study centres) included in the dossier for marketing authorization application although there is no legal base for this. That truly sucks. Hand them an inspection certificate or -in panic situations- an audit certificate and pray. ❝ However, to my knowledge there had been some discussions at EMA whether to issue GCP certificates or not but I do not know the outcome. Someone else? No idea?!? I could imagine this would have to be escaladed to EU Commission level if it were to become practice. I could imagine we would see a directive amendment as a first sign of something brewing. I think it could quickly go very political, since in some countries the agencies cannot charge for inspections while they can in other countries, and inspection availability ultimately depends on funding. Another clear answer from ElMaestro... perhaps, no idea, I dunno, yes and no, possibly. And I could be wrong, even when I say "perhaps".  — Pass or fail! ElMaestro |
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cakhatri ★ India, 2012-10-09 09:16 (4595 d 06:45 ago) (edited on 2012-10-09 09:59) @ Helmut Posting: # 9347 Views: 6,395 |
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Hi Helmut, That automated google was interesting one. Thanks for the information. The link provide a good amount of information but as you rightly said its only for FIM studies Regards Chirag 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! [Ohlbe] |
Ing. Helmut Schütz