Quality Management System
Organization
Eurofins companies have established quality management system based on internationally harmonized guidelines (ICH-Q10).
We comply with PIC/S guidelines which are regulatory requirements in Japan, the United States, and Europe, and we extensively support operations from the early development to commercial production.
Eurofins Biopharma Product Testing network of companies operates under the same global quality policy manual enabling us to ensure the same level of high quality service at any of our facilities.
Data integrity
We comprehensively manage testing services from sample receipt to report by utilizing eLIMS-BPT developed and validated by Eurofins BPT network of companies.
We have established system to ensure data integrity throughout life cycle data management. Our experts strictly review data.
Inspection by authorities
| Year and Month | Institution | Type of inspection | Results |
| March, 2016 | Kyoto Prefecture Health and Welfare Department | On-site | Complied |
| August, 2016 | FDA | On-site | Complied |
| September, 2016 | PMDA | On-site | Complied |
| July, 2020 | Kyoto Prefecture Health and Welfare Department | On-site | Complied |
| March, 2021 | PMDA | On-site | Complied |
| July, 2021 | PMDA | Paper | Complied |
| July, 2021 | FDA | Paper (Form 4003a) | No Issues Identified |
| Sep, 2023 | FDA | Paper (Form 4003) | No Issues Identified |
| Oct, 2022 | Kyoto Prefecture Health and Welfare Department | On-site | Complied |
| Dec, 2022 | PMDA | Paper | Complied |
| May, 2023 | Kyoto Prefecture Health and Welfare Department | On-site | Complied |