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