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QUALITY SYSTEM

The Ar.la.ve.s. Quality System is certificated according with ISO 9001:2008 and ISO 15378:2006 - Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practices (GMP).
The Drug Master File (DMF type 3 - No. 15544) is registered at FDA, the Food and Drug Administration of USA.

Download ISO 9001 and ISO 15378 certificates
QUALITY CONTROL
THE QUALITY CONTROL SYSTEM FULLY INVOLVES EVERY STEP OF THE PROCESS: FROM THE RAW MATERIALS APPROVAL TO THE AUTOMATIC AND STATISTICAL IN-PROCESS CONTROLS, AS FAR AS THE FINAL APPROVAL AND RELEASE OF THE BATCH.
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DATA BREAK
Lan of line instruments to check the breaking force, with automatic data recording and monitoring on host computer.
GIANT SQL
Electronic recording and management of quality controls data.
QUALITY REPORT
An analytic Quality Certificate is delivered attached to each batch . Detailed data of the control results, traceability of the raw materials and the conformity declaration of the batch, are supplied in a detailed documentation.