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Quality


Accreditations & Approvals


Internal Quality and EHS Accreditations

- Received ISO 9001 accreditation in 1993 and recertification
  for ISO 9001:2008

- Implemented an integrated Environment, Health and
  Safety management system

- ISO 14001:2004 certification

- OHSAS 18001:2007 certification


Facility Approvals

  • USFDA acceptance for GMP compliance; Biocon Campus (2000, 2003, 2006,  2009 and 2012) and Biocon Park (2006,  2009 and 2012)

  • EUGMP Certification for drug substances manufactured at Biocon Campus (2005, 2006, 2008, 2009, 2010 and 2011) and Biocon Park (2006, 2009, 2010 and 2011)

  • EUGMP certification by EMA through Irish Medicines Board for Human Insulin (rDNA origin) Drug substance facility located at Biocon campus in 2012

  • TGA certification in 2009 (based on desk top audit) for both Campus and park facilities. Most recent inspection in 2012 was at Hyderabad facility

  • Mexican Health Authority approval (COFEPRIS) for drug substances manufactured at Biocon campus in 2006 and 2010 . Recent inspection in 2012

  • Korean FDA certification for both Biocon campus and park facilities in 2009 and the most recent inspection in 2012

  • Cuban approval for both Biocon Campus and Biocon Park facilities in 2007

  • Jordan FDA approval for both Biocon Campus and Biocon Park facilities in 2008

  • Anvisa (Brazil) approval for both Biocon Campus and Biocon Park facilities in 2008

  • Saudi FDA approval for Biological facility at Biocon Campus in 2010

  • The Iran Ministry of Health certification in 2011 for both Biocon campus and park facilities for Biologicals

  • Iran MOH certification 2012

  • Nepal Health Authority certified park facility for Nimotuzumab in 2009

  • Yemen Ministry of Health certification for Biologicals for Biocon campus and park facilities in 2010

  • Zimbabwe Ministry of Health  certified fill finish facility at Biocon park in 2010

  • Oman Ministry of Health  certified fill finish facility at Biocon park in 2011

  • Ghana Ministry of Health  certified fill finish facility at Biocon park in 2011

  • Kenya Ministry of Health  certified fill finish facility at Biocon park in 2011

  • Tanzania FDA certified fill finish facility at Biocon park in 2011

  • Ivory Coast Ministry of  Health  certified fill finish facility at Biocon park in 2011

  • Malawi Ministry of Health  certified fill finish facility at Biocon park in 2012

  • Colombia Ministry of Health  certified fill finish facility at Biocon park in 2012

  • Schedule – M GMP Certification for both Biocon Campus and Biocon Park facilities as per D&C act, India.

    Other credentials:

  • Golden Peacock National Quality Award for Quality is awarded by Institute of Golden Peacock Awards, India in January 2012

 
     
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