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 | AEMPS (Nov 2020), K-FDA, Japanese Accreditation, Russian H.A. (May 2021) | Generics / CM |
M. CANTABRA | 2010 | October 2015 | AEMPS (Jan 2018), TGA, Japanese Accreditation | Generics / CM |
COPRIMA | 2001 | February 2016 | AEMPS (Dec 2018), Cofepris, Japanese Accreditation | Generics |
MOEHS BCN | 2019 | July 2019 | AEMPS (Jan 2018), Japanese Accreditation | Generics / CM |
BENECHIM | 2013 | February 2016 | AFMPS-Belgium (Jan 2021), Japanese Accreditation | Generics / CM |
NORCHIM | 1989 | June 2017 | AFSSAPS-France (Dec 2018), Japanese Accreditation | Process Research CM |
C.F. BERG | 2002 | June 2018 | BfArM-Germany (Dec 2017), K-FDA, Japanese Accreditation | Generics / CM |
MGRC | - | - | AEMPS (Jul 2020) | Generics / CMDO |
PROTEOS BIOTECH | - | - | AEMPS (May 2017) | Biotechnology |