CGMP Compliance - Moehs
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CGMP Compliance

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 2017), TGA,
Japanese Accreditation
Generics / CM
COPRIMA 2001 February 2016 GenCat (Nov 2015), Cofepris,
Japanese Accreditation
Generics
MOEHS BCN - - AEMPS (Jan 2017) Generics / CM
BENECHIM 2013 February 2016 AFMPS-Belgium (Jan 2018),
Japanese Accreditation
Generics / CM
NORCHIM 1989 June 2017 ANSM-France (Dec 2014),
Japanese Accreditation
Process Research CM
C.F. BERG 2002 May 2015  BfArM-Germany (Dec 2014),
K-FDA, Japanese Accreditation
Generics / CM
PROTEOS BIOTECH  AEMPS Biotechnology

· ICH Q7 compliance
· Compliance to USP, EP, JP,ND
· More than 30 CEPs Issued
· 28 USDMF filed at the FDA