Bioindustria L.I.M. : Quality System

".. guarantee that production follows the correct procedures "

The Quality Assurance Department together with Quality Control, guarantee that production follows the correct procedures of current Good Manufacturing Practices (cGMP) to assure the highest possible quality standards.

Our Quality System is based on written SOP's, validations, equipment qualification, change controls, deviations management, quality annual reviews, scheduled training and self audits.

  • [ sop's ]
  • General System Management
  • Analytical Laboratory
  • Warehouse
  • Production
  • Maintenance
  • Safety
  • Technical Instructions
  • [ validation on ]
  • General System Management
  • Analytical Laboratory
  • Warehouse
  • Production
  • Maintenance
  • Safety
  • Technical Instructions


All our products are supported by DMF that is filed in house by Bioindustria L.I.M. staff and managed by the Regulatory Affairs Unit.

Our Quality System has been recognised by the FDA approval (the last inspection of the plant was in May 2011), and AIFA (Italian Ministry of Health) following an inspection of the plant and of the analytical laboratories (last inspection in August 2013) and the subsequent release of a GMP certificate for the manufacturing of API.

Biondustria has been successfully audited by major Italian and foreign pharmaceutical companies and their respective countries' Health Authority.
Bioindustria L.I.M. is always accessible to customers audits.


  • [ controls on ]
  • Batch Production records
  • Product Specifications
  • Analytical Methods
  • SOP's
  • Validation Documentation
  • [ training on ]
  • cGMP
  • Safety
  • Processes
  • Internal Procedures
  • Technical Issues


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