Since 1996, we are ISO 9001 certified, the Quality Certification for our products, and ISO 15378 certified (a specific integration between GMPs and the ISO 9001 standard, regarding manufacturers of primary packaging materials for medicinal products).
Our “Quality Team” has evolved and expanded with the addition of many new professional roles.
Some come from the Pharma sector and this has meant a significant jump forward in terms of quality of Operational Procedures management, review of the Quality Manual, management of Inspection Audits as well as implementation of personnel training plans.
As of today, we can count on eighteen people – in three plants – members of the Quality Team, engaged in production as well as a QA manager who works with five lab resources spread throughout the various facilities.
Inside our business units, each product lot begins with the creation of a batch record, which contains all the production variables occurred during production. This is saved in our archives for 5 years after the shipment date.
Each lot has a unique number and there can never be an identical one. This special number is used during the entire span of production and it appears on all the documents we create (order confirmation, transport document, invoice, box label, pallet label, screen print film – where it applies – and certificate of lot clearance).
This number allows us to obtain almost total traceability and to identify a batch in terms of: raw material, hour/day of begin/end production, line of production, operator’s name, QC supervisor’s name, shift technician in charge and warehouse person.
At the end of production, we can issue a lot clearance certificate summarizing all the controls performed and their results, certification of use of a certain raw material and of the parameters set to manufacture the product.
All our staff, regardless of position, undergoes constant training and is qualified by the QA.