We monitor compliance of the GMP Standards
Compliance with GMP standards is supervised by our qualified staff. This team manages the different elements of the Quality system, including:
Validation Master Plan
Internal audits
Investigation of Process Deviations
Claims and OOS
Change control
SOPs. Standard Operating Procedures
Training
Supplier qualification
Our facilities are frequently audited by our clients and regularly inspected by different authorities.
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 |