A specialized staff supervises the compliance with cGMP standards requirements for all the organization. This team manages the different elements of the quality system, including:
A specialized staff supervises the compliance with cGMP standards requirements for all the organization. This team manages the different elements of the quality system, including:
Validation Master Plan
Internal Audits
Investigation of process deviation
Complaints and OOS
Change controls
SOPs
Training
Raw material suppliers’ qualification
Our facilities are regularly inspected by our clients and have been routinely inspected by different authorities
FDA inspected since |
Latest FDA inspection |
Other inspections | Activity | |
---|---|---|---|---|
M. CATALANA | 1984 | May 2018 | AEMPS (Sept 2017),K-FDA,
Japanese Accreditation, Russian H.A. (July 2017) |
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 | July 2019 | July 2019 | AEMPS (Jan 2017),
Japanese Accreditation |
Generics / CM |
BENECHIM | 2013 | February 2016 | AFMPS-Belgium (Jan 2018),
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 |
PROTEOS BIOTECH | AEMPS (May 2017) | Biotechnology |
· ICH Q7 compliance
· Compliance to USP, EP, JP,ND
· More than 30 CEPs Issued
· 28 USDMF filed at the FDA