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 sinceOther inspectionsActivity
M. CATALANA1984May 2018ANVISA-Brazil (2023), AEMPS-Spain (Nov 2023), Russian H.A. (May 2021), K-FDA (2011), Japanese AccreditationGenerics / CM
M. CANTABRA2010Oct 2015ANVISA-Brazil (2023), AEMPS-Spain (Nov 2022), TGA (2010), Japanese AccreditationGenerics / CM
COPRIMA2001Feb 2016

AEMPS-Spain (Dec 2022), Japanese Accreditation

Generics
MOEHS BCN2019July 2019AEMPS-Spain (Nov 2023), Japanese AccreditationGenerics / CM
MOEHS IBÉRICA, MGRC2023

Nov 2023

AEMPS-Spain (Nov 2023)

Development

Generics / CM
BENECHIM2013Feb 2016AFMPS-Belgium (Jan 2021),  Japanese AccreditationGenerics / CM
NORCHIM1989June 2017

AFSSAPS-France (Dec 2022), Japanese Accreditation

Process Research CM
C.F. BERG2002June 2018

BfArM-Germany (Nov 2020), Russian H.A. (Nov 2019), K-FDA, Japanese Accreditation

Generics / CM
  • Compliance with ICH Q7
  • Compliance with USP, EP, JP, ND
  • More than 30 CEPs presented
  • 28 USDMF registered with the FDA