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BA1 ☆ 2009-06-08 16:21 (6226 d 03:54 ago) Posting: # 3833 Views: 3,986 |
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Dear All, I would request you if you can help me in this regard: Non-clinical SEGMENT-2 TOX STUDIES aligning to GLP are carried out in lab 'A' which is a GLP certified Lab in India following OECD principles and the toxicokinetic and formulation samples have been sent to Lab 'B' which is accreditated by NABL aligning to ISO/IEC 17025:2005 standard, and after the study the Lab 'A' will compile the data received from Lab 'B' as per GLP and submit to USFDA GLP. My query is - the bioanalytical data generated from Lab 'B' (which has NABL accreditation and Quality and Technical system aligning to ISO/IEC 17025:2005) is acceptable by USFDA GLP or not? The live phase and pharmacokinetic analysis will be done in GLP certified Lab 'A' and final report is also be generated by Lab 'A'only. Please guide me in this matter, I had looked into OECD guidelines also but I could find the relevant answer for my query. |
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Helmut ★★★   Vienna, Austria, 2009-06-08 17:13 (6226 d 03:02 ago) @ BA1 Posting: # 3834 Views: 3,292 |
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Dear BA1, as an entry point see FDA's comparisons charts for differences between GLPs (FDA/EPA/OECD): HTML, PDF. — 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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BA1 ☆ 2009-06-10 15:54 (6224 d 04:20 ago) @ Helmut Posting: # 3841 Views: 3,198 |
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Dear Sir, Thank you for guiding me. |
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BA1 ☆ 2009-06-11 11:44 (6223 d 08:30 ago) @ Helmut Posting: # 3846 Views: 3,157 |
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Dear Sir, In continuation to my previous mail regarding the ISO/ IEC accreditation and GLP certification, we are planning go ahead for GLP certification for our organization. The services offered by us is Bioanalytical where we support BA/BE and Toxicokinetics studies, we are not involved in pre-clinical and clinical live phase, the samples which arrive at our end are analysed and the obtained values are reported. And my query is in which area of expertise can we apply for National GLP in India? And one of the consultant gave his feed back that they give GLP certification only when live phase is also involved. Can you please guide us in this matter.  |
Ing. Helmut Schütz