Quality is more than a set of rules; it is a state of mind.

At Hovione, every single employee is responsible for quality. Our approach has established a quality culture within the company that impacts everything we do. At the heart of our quality standards is patient safety. Setting, delivering and sustaining quality is based not only on our internal systems, but also on a collaborative and transparent relationship with our customers and industry regulators.

"Hovione values of transparency and integrity are highly aligned with ours"

US Biotech, West Coast

Our Quality System is designed to guarantee and demonstrate cGMP compliance, as well as satisfying the regulatory and legal requirements that govern the manufacture of our products, wherever we manufacture and sell them.

Our approach to quality always considers innovation, productivity and continuous improvement.

Quality Management System

Hovione’s Quality System is based on a set of regulations and guidelines, mainly the European GMP guidance as published in Eudralex, Volume 4, Parts I and II and applicable annexes, the USA 21CFR, Parts 210 and 211, the Japanese GMP Ministerial Ordinance, the ICH applicable guidelines and sites’ local regulations.

Quality is the responsibility of all staff at all levels from all departments/areas within the sites’ organization, including suppliers and service providers, to ensure that all products through their life-cycle are manufactured according to GMP, applicable guidelines and regulatory requirements, to fit their intended use.

The Quality Management System encompasses an organizational structure, resources, processes and a set of controlled procedures, including a risk management procedure necessary to ensure that products have the required purity, strength and safety, as defined in the regulatory filings.

The performance and effectiveness of the system is assessed periodically through the information of most relevant quality metrics and at least once a year by top management in the so called “Formal Review”, where each department presents its achievements, weaknesses, strengths and objectives for the following year and the Top Management has the opportunity to evaluate the performance either by product and of the global Quality and HSE Systems and to identify areas for improvement and/or to define/approve the appropriate actions.

 

Also in Quality and Compliance

Health, Safety, Environment and Energy (HSEEn)

Zero accidents is our main goal

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Regulatory Affairs

Hovione has filings with every world health authority that has a DMF system for APIs including FDA EDQM PMDA,MHRA, HPRA, Infarmed among others.

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