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 on July 2001), following an inspection of the plant and of the analytical laboratories; as well as many successful audits by major Italian and foreign pharmaceutical companies and their respective countries' Health Authority. Bioindustria L.I.M. is always accessible to customers audits.

Last Italian Ministry of Health inspection (January 2008)

• [ controls on ]
• Batch Production records
• Product Specifications
• Analytical Methods
• SOP's
• Validation Documentation

• [ training on ]
• cGMP
• Safety
• Processes
• International Procedures
• Technical Issues