Authorizations
GMP CERTIFICATE: Chelab has been inspected by the Italian Competent Authority (AIFA) under the national inspection programme in connection with manufacturing authorisation n. aM - 153/2010 in accordance with art. 40 of Directive 2001/83/EC. The GMP certificate states that Chelab complies with the Good Manufacturing Practice (GMP) requirements referred to The principles and guidelines of GMP laid down in Directive 2003/94/EC (certificate nr. IT/1-1/H/2011).
QUALITY CONTROL LABORATORY AUTHORIZATION FOR MEDICINAL PRODUCTS FOR VETERINARY USE: Chelab has been authorised by the Italian Ministry of Health as contract Quality Control laboratory for microbiological, chemical/physical and biological testing of Medicinal Products and active pharmaceutical ingredients for veterinary use (authorisation N./14/2011/V).
GMP CERTIFICATE: Chelab has been inspected by the Italian Competent Authority under the national inspection programme in connection with manufacturing authorisation N./14/2011/V in accordance with art. 44 of Directive 2001/82/EC. The GMP certificate states that Chelab complies with the Good Manufacturing Practice (GMP) requirements referred to in The principles and guidelines of GMP laid down in Directive 91/412/EC.
CLINICAL LABORATORY AUTHORIZATION: Authorization as clinical laboratory in the specified category of testing: quali-quantitative determination of drugs and metabolites (bioanalytical studies supporting clinical trials), illicit drug testing and genetic individual identification and paternity determination (authorization prot. 13933 of 06/11/2009).
QUALIFICATION AS LABORATORY INVOLVED IN CLINICAL TRIALS (BIOANALYTICAL PART OF BIOEQUIVALENCE TRIALS AND PHASE-I CLINICAL TRIALS) OF MEDICINAL PRODUCTS by the local health authority (ASL) in accordance with art. 1 of italian DM 19/03/1998 (27/01/10);
INSERTION IN REGISTER OF PRIVATE CLINICAL LABORATORIES INVOLVED IN CLINICAL TRIALS (bioanalytical part of bioequivalence/bioavailability trials and phase-I clinical trials of medicinal products) by OsSC (National Monitoring Centre on Clinical Trials of Drugs) (17/03/2010).
AUTHORIZATION FOR USE OF INTERNATIONALLY CONTROLLED SUBSTANCES: authorization of Italian Ministry of Health for use, only for analytical control, of substances listed both in the “List of narcotic drugs under international control” (YELLOW LIST 48th edition December 2008) and in the “List of psychotropic substances under international control” (GREEN LIST 23th edition August 2003) as well as in Tab. I and II of Italian DPR 309/90 (authorization nr. 13742).
GLP CERTIFICATE: The Italian GLP monitoring authority (Italian Ministry of Health) certifies that Chelab test facility is included in the national GLP Compliance Programme, is inspected on a regular basis and is in compliance with the OECD Principles of Good Laboratory Practice in the conduct of non-clinical health and environmental safety studies of test items within the following area of expertise: Physical-chemical testing, Toxicity studies, Mutagenicity studies, Environmental toxicity studies on aquatic & terrestrial organisms, Behaviour studies in water, soil, air, Bioaccumulation studies, Residue studies, Analytical and clinical chemistry testing, Elimination and/or inactivation of viruses, other studies. (certificate nr. 86/2009)
AUTHORIZATION FOR USE OF ANIMALS FOR EXPERIMENTAL PURPOSE: authorization of Italian Ministry of Health for use of animals (fish) for experimental and scientific purposes in accordance with art. 12 of italian D.Lgs 116/92 (DM n° 74/2011-A on 04/27/2011) and for use of fishes in ecotoxicology tests (DM n° 94/2011-B on 05/24/2011)
INCLUSION IN THE LIST OF APPROVED LABORATORIES THAT ARE COMPETENTTO CARRY OUT THE TESTS REQUIRED BY THE REGULATION EC 648/2004,
according to Article 8(2) of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents. LINK
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