Compliance with GMP standards

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 sinceLatest FDA inspectionOther inspectionsActivity
M. CATALANA1984May 2018AEMPS (Nov 2020), K-FDA, Japanese Accreditation, Russian H.A. (May 2021)Generics / CM
M. CANTABRA2010October 2015 AEMPS (Jan 2018), TGA, Japanese AccreditationGenerics / CM
COPRIMA2001February 2016AEMPS (Dec 2018), Cofepris, Japanese AccreditationGenerics
MOEHS BCN2019July 2019AEMPS (Jan 2018), Japanese AccreditationGenerics / CM
BENECHIM2013February 2016AFMPS-Belgium (Jan 2021), Japanese AccreditationGenerics / CM
NORCHIM1989June 2017AFSSAPS-France (Dec 2018), Japanese AccreditationProcess Research CM
C.F. BERG2002June 2018BfArM-Germany (Dec 2017), K-FDA, Japanese Accreditation Generics / CM
MGRC--AEMPS (Jul 2020)Generics / CMDO
PROTEOS BIOTECH--AEMPS (May 2017)Biotechnology

Compliance with ICH Q7

Compliance with USP, EP, JP, ND

More than 30 CEPs presented

28 USDMF registered with the FDA