The Stevanato Group projects and produces containers for pharmaceutical use, that actually become part of a pharmaceutical product. Spami, which belongs to the Engineering Division of the Stevanato Group, is specialized in projecting and producing forming machines and control systems for glass tube containers such as vials, cartridges, syringes, ampoules, and special use containers.

Quality of the product means also Safety for patients (including all of us).

Guiding Principles

This principle is the base of GMP (Good Manufacturing Practices), that represents the quality management system orientation in addition to ISO standards.

The Stevanato Group defined the guiding principles listed below:

• we don't control quality, we produce it
• cleanliness, order, method and knowledge are necessary conditions to produce quality
• teamwork and orderly personnel involvement are the basis of success
• customer specifications and applicable GMP aspects should always be considered in every decision
• concrete elements (such as data or samples) should always be available during any discussion
• there are no phase of the process that cannot be improved
• the suppliers must also be involved in the improvement process
• the competitors should be considered as a reference to evaluate improvement possibilities
• the validation of a process makes it more stable and repetitive with immediate quality confirmation; the machine qualification makes its use safer and predictable with immediate quality and safety confirmation
• any change regarding a validated or consolidated condition could bring about unexpected consequences so it should first be evaluated by a change control protocol. 

General Objectives

The organization has adopted a mechanism of definition of objectives by function based on their planning by the person Responsible and the Management.

Those objectives are defined during the budget compilation and they are harmonized to be coherent with the economic, financial and quality targets.

The Management fixes and registers the objectives, and maintains their registration during the budget planning. Any gaps are identified and possible countermeasures are adopted.

Quality Objectives

The stated objectives are reviewed and reported in the "Management Review Report". During the review, the Management evaluates the situation represented in the report prepared by the QA department and defines the actions for improvement needed for:

• patient safety;
• product conformity
• orientation to the customer
• GMP conformity
• Quality Management System conformity
• "Right first time".