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Accreditations

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Eurofins BioPharma Product Testing Laboratories are accredited by the following italian and international institutional accreditor:

1. AIFA authorisation to perform in compliance with good medical manufacturing practices (GMP) biological, microbiological, chemical-physical and chemical quality controls on medicines and active pharmaceutical ingredients for human use.
Eurofins Biolab Vimodrone Site (English translation of AIFA GMP Authorization - PDF)
(GMP Certificate - PDF
Eurofins Biolab Poggibonsi Site (GMP Certificate - PDF)

2. Report audit FDA. FEI (Facility Establishment Identification):
n. 3002806530 for Eurofins Biolab in Vimodrone
n. 3010492524 for CTP Laboratories in Poggibonsi
(Report 2013 - PDF) (Report 2015 - PDF)
(FDA Generic Drug Facility Identification Submission - PDF EN)
(FDA Establishment Registration - PDF EN)

3. Italian Ministry of Health authorisation to perform the following types of analysis in accordance with the principles of good laboratory practices (GLP) since 1991.
(GLP provisional certificate of compliance 2015 - PDF) (GLP certificate of compliance 2013 - PDF)

4. ISO/IEC 17025 accreditation by Accredia (National System for the Accreditation of Laboratories), since 1992.
(Certificate - PDF) (List of accreditated tests Milano - link to Accredia)

5. Italian Ministry of Health authorisation to perform in compliance with good medical manufacturing practices (GMP) biological, microbiological, chemical-physical and chemical quality controls on medicines and active pharmaceutical ingredients for veterinary use since 1991.
Eurofins Biolab Vimodrone Site (Certificate - PDFEurofins Biolab Poggibonsi Site (Certificate - PDF)

6. ISO 9001 Certification for the following operative sites: Eurofins Biolab - Vimodrone, Eurofins Biolab - Poggibonsi and Kalibios - Rome, Quality System released from Certiquality for planning and provision of scientific, professional and technical services such as: advice, controls and checks, studies and laboratory tests on safety and quality of products and processes; planning and provision of training courses. (Certificate - PDF)

7. 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)

8. ISO 22716 (GMP cosmetics) certification for the company's Quality System released from Certiquality to perform analytical service on cosmetics products. (Certificate - PDF)

9. Italian Ministry of Health authorisation to perform chemical, chemical-physical, microbiological and technological controls on PMC (presidi medico chirurgici).

10. 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.

11. Italian Ministry of Health authorisation to keep narcotics for scientific purposes in accordance with D.P.R. 309 dated 9 October 1990 for Eurofins Biolab site and CTP Laboratories site.

12. 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 Biolab site and CTP Laboratories site.

13. Inclusion in the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL)
(Membership - PDF)

14. French Ministry of Higher Education and Research approval as an organization carrying out R&D activities on behalf of private companies since 2009. (Decision d'agrement - PDF FR)

15. DGHM/VAH accreditation on efficacy studies of disinfectant products in the medical area for the German regulatory.
(Accreditation 2010 - PDF) (Certificate 2011 - PDF EN)
(Certificate VAH 14561-2006 - PDF) (Certificate VAH draft WI 00216049 - PDF)

16. Italian Ministry of Health authorisation in accordance with D.Lgs 12.04.2001, n. 206 for the use of genetically modified microorganisms for analytical activities. (Authorization - PDF)