Eurofins BioPharma Product Testing laboratories in Italy, Vimodrone and Poggibonsi sites, are accredited by the following italian and international institutional accreditors. Please check below the specific accrediations for each site.
AIFA authorisation to perform in compliance with good medical manufacturing practices (GMP) biological, microbiological, chemical-physical quality controls on medicines and active pharmaceutical ingredients, included importation and experimental products for human use.
Italian Ministry of Health authorisation to perform in compliance with good medical manufacturing practices (GMP) biological, microbiological, chemical-physical quality controls on medicines and active pharmaceutical ingredients, including importation for veterinary.
FEI (Facility Establishment Identification)
FDA Report Audit (Vimodrone site)
Italian Ministry of Health authorisation to perform the following types of analysis in accordance with the principles of good laboratory practices (GLP): physical-chemical testing, toxicity studies, environmental toxicity studies on aquatic or terrestrial organisms, studies on behaviour in water, soil and air; bioaccumulation, lal test, inactivation and removal studies of pathogens, biocompatibility studies, microbiology studies, biocidal/virucidal activity studies.(GLP certificate - PDF)
Accredia Accreditation, since 1992 with reference to UNI CEI EN ISO/IEC 17025 standard attesting to the technical competence to the accredited tests of the laboratories in Eurofins BioPharma Product Testing Italy.
(Certificate - PDF) (Significance and characteristics of ISO/IEC 17025 accreditation - PDF)
A2LA accreditation, from 2021, with reference to ISO/IEC 17025:2017 and A2LA specific requirements "R256 - Specific Requirements - FDA ASCA Program" attesting the technical competence of Eurofins BioPharma Product Testing laboratories in Italy in relation to the accredited tests.
(Certificate - PDF)
Ministry of Food Agriculture and Livestock of Turkey authorisation to perform in compliance with good manufacturing practices (GMP) microbiological non-sterility and checmical-physical quality controls on medicines and active pharmaceutical ingredients for veterinary use.
(Certificate - PDF)
ISO 9001 certification for the company's Quality System released from Certiquality for planning and provision of scientific, professional and technical services such as: controls (including sampling activities), assessment and laboratory studies on efficacy, safety and quality of products and processes, technical assistance. Production and dealing of chemical and microbiological products used in microbiological laboratories of analysis.
(Certificate - PDF)
ISO 13485 certification for the company's Quality System released from Certiquality for the design and development of protocols of microbiological and physico-chemical characterization, and biological evaluation of medical devices, validation of critical processes (washing, disinfection, sterilization and packaging) and production sites in the biomedical fields. Service provider of tests and inspections relating to medical devices.
(Certificate - PDF)
Italian Ministry of Health authorisation to perform chemical, chemical-physical, microbiological and technological controls on PMC (presidi medico chirurgici).
(PMC Authorization n. 30-2012 - PDF)
Inscription in the registry of highly qualified laboratories authorised to develop applied research for small and medium-sized industries in accordance with Article 4 of Law no.46 dated 27 February 1982.
Italian Ministry of Health authorisation to keep narcotics for scientific purposes in accordance with D.P.R. 309 dated 9 October 1990 for Eurofins BioPharma Products Testing laboratories in Italy located in Vimodrone and Poggibonsi.
Italian Ministry of Health authorisation in accordance with art. 32, 36, 37 "Uniform Laws and Regulations of narcotic drugs and psychotropic substances", approved by D.P.R. 309 dated 9 October 1990. Drug precursors license for Eurofins BioPharma Products Testing laboratories in Italy located in Vimodrone and Poggibonsi.
Inclusion in the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL).
(Membership - PDF)
DGHM/VAH accreditation on efficacy studies of disinfectant products in the medical area for the German regulatory.
CIR accreditation approved by the French Ministry of Higher Education, Research and Innovation as an organisation carrying out R&D activities for the account of private companies.
(Accreditation - PDF FR-EN)
ISO 14001:2015 as part of the effort and our committment to implement a sustainable environment that encompasses all our sites.
(Certificate - PDF)
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