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 | 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 |