Favia Quality System
Compliance with the Highest Standards in every Working Phase
Tubettificio Favia has conformed its production processes to the needs of its main customers: the pharmaceutical companies. As a result, the company strives to comply with the most stringent standards of quality and efficiency.Great attention is paid to product control and compliance with procedures, thanks to the support of a powerful information system and the creation of dedicated workflows that allow to reduce the risks and keep company processes under control. The efficiency of the Quality System ensures at any time that:
- the product is printed according to specifications
- only approved materials are used
- product is of top quality
- each single batch can be completely traced.
Implementation of Favia Online Portal has been an important development in the management of deliveries and in communications with customers, at the advantage of both parties.
Internal Quality System is based on the ISO EN 9001:2008 rules and the Good Manufacturing Practices, in order to guarantee all internal processes and company activities, from the development of new products till the delivery of the finished products and their possible irradiation.
- ISO certification was issued by the certifying body DNV GL Business Assurance in 1999 and is regularly renewed.
- Moreover, Tubettificio Favia has submitted to FDA (Food and Drug Administration) its DMF relating to the production of collapsible aluminium tubes.
- In addition to the ISO certification, the company has been validated by qualified national and foreign customers, as well as by Gruppo Ispezione Fornitori, an inspection group belonging to AFI (Industrial Pharmaceutical Association) within AICQ, that groups more than 40 Italian pharmaceutical companies.
Besides complying with all requirements under the Quality System ISO EN 9001, Tubettificio Favia also guarantees all the aspects specifically required by the production of pharmaceutical packaging.
The production environments have been established to ensure the hygiene of the products and to avoid any kind of contamination.
According to an accurate internal control, periodic analyses are carried out on the products and in the production area in order to keep any kind of microbial and particle contamination under control. Data and results arising from the analyses are yearly summed up and assessed in a specific document.
Thanks to a thorough analysis of the risks, all critical operations have been identified and properly handled, the cleaning of the line, the end-of-line checks and the sampling.
The whole production process to the release of the batches is managed and traced through a dedicated workflow.
Favia can ensure the exclusive use of materials approved by customers, in accordance with applicable regulations.
Favia Information system allows to provide the customers with all updated documents relating to each material used in the production process.
As for the supply of raw materials, Favia exclusively relies on qualified suppliers that can ensure the necessary requirements, which are assessed according to the service provided and the quality of their products.
For more critical materials, acceptance checks providing particular tests in laboratory and in production are carried out. They are approved through a strict control of quality, which is also managed with an appropriate workflow.
Batches of materials used in the production of aluminium tubes are registered in the information system to guarantee the traceability of each production order. These data can be indicated in the Certificate of Compliance which is available for the customers, in digital format or, on request, in paper format.