Quality
Since 2022, 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.
To date we can count on ten people in our plant, members of the Quality Team, involved in production as well as a QA manager who works with five laboratory resources distributed throughout our 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 3 years after the shipment date.
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.
To date we can count on ten people in our plant, members of the Quality Team, involved in production as well as a QA manager who works with five laboratory resources distributed throughout our 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 3 years after the shipment date.
