CGMP Compliance - Moehs
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CGMP Compliance

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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