Reliable, Accurate and On-Time
분석은 육안으로 볼 수 없는 것을 기술의 힘으로 보는 것입니다.
더 정확히 더 자세히 볼수록 더 안전하고 더 유용해 집니다.
Audit Date | Organization | Audit Type |
---|---|---|
2008 Oct | MFDS Korea | KGLP Regular, Biennial |
2009 Jan | MFDS Korea | BE Regular, Biennial |
2012 Aug | WHO(USP) | Pre-Qualification |
2012 Oct | Pfizer | Vendor/BE Study |
2014 Sep | Sanofi | Vendor/BE Study |
2016 Dec | Astellas | Pre-Qualification |
2019 Mar | MFDS Korea | KGCLP Regular, Biennial |
2019 Jun | Merck | Vendor Assessment |
2022 Nov | MFDS Korea | KGCLP Irregular (New Site) |
ISR Reproducibility of BioInfra far Surpassing
ICH Requirements
Total No of ISR Samples | Difference within ±10% | Difference within ±20% | |
---|---|---|---|
ICH Requirement | N.A. | N.A. | 67% |
BioInfra 2017 | 7,896 | 97.33% | 99.73% |
BioInfra 2018 | 8,233 | 97.33% | 99.83% |
BioInfra 2019 | 17,674 | 97.85% | 99.74% |
BioInfra 2020 | 18,164 | 97.95% | 99.66% |
BioInfra 2021 | 24,935 | 98.00% | 99.90% |
BioInfra 2022 | 29,052 | 98.25% | 99.81% |