我们监督并遵守遵循
GMP标准
GMP标准的遵守情况由专业人员监督。
该团队管理质量体系为此制订了具体的方案,包括:
验证规划
内部审计
工艺偏差调查
声明和OOS
变更控制
标准操作程序
人员培训
供应商资质
我们的工厂经常接待来自客户以及不同国家当局的审计。
FDA inspected since | Latest FDA inspection | Other inspections | Activity | |
---|---|---|---|---|
M. CATALANA | 1984 | May 2018 | ANVISA-Brazil (2023), AEMPS-Spain (Nov 2023), Russian H.A. (May 2021), K-FDA (2011), Japanese Accreditation | Generics / CM |
M. CANTABRA | 2010 | Oct 2015 | ANVISA-Brazil (2023), AEMPS-Spain (Nov 2022), TGA (2010), Japanese Accreditation | Generics / CM |
COPRIMA | 2001 | Feb 2016 | AEMPS-Spain (Dec 2022), Japanese Accreditation | Generics |
MOEHS BCN | 2019 | July 2019 | AEMPS-Spain (Nov 2023), Japanese Accreditation | Generics / CM |
MOEHS IBÉRICA, MGRC | 2023 | Nov 2023 | AEMPS-Spain (Nov 2023) | Development Generics / CM |
BENECHIM | 2013 | Feb 2016 | AFMPS-Belgium (Jan 2021), Japanese Accreditation | Generics / CM |
NORCHIM | 1989 | June 2017 | AFSSAPS-France (Dec 2022), Japanese Accreditation | Process Research CM |
C.F. BERG | 2002 | June 2018 | BfArM-Germany (Nov 2020), Russian H.A. (Nov 2019), K-FDA, Japanese Accreditation | Generics / CM |