We are wholly committed to Quality. Our operations are centered on proven and effective processes that deliver dependable results. We aim to do it right first time and to assure the highest quality as well as the safety of our products for all patients.
Our Quality System is designed to guarantee and evidence compliance with cGMPs and with the regulatory and legal requirements that govern the manufacture of our products wherever we manufacture and sell them.
The effectiveness of our Quality System requires a strong and mature Quality Culture that we nurture by setting the example, coaching all team members, delegating responsibilities and developing the young people who will build the Hovione of the future. To this end, we need to provide everyone with reference points and standards that can be used as a compass to set direction and to help take the right decisions. Our Policies (Quality, HSEE, Human Resources, Innovation & Entrepreneurship) communicate and document our values.
A compliance audit is a must-have tool in every vendor qualification program. It is used to assess the supplier’s Quality Management System and its compliance with applicable regulations. We believe that the resources put currently into audits need to be re-thought and rationalized for better returns.
Much of the decision-making around audits (frequency, length and depth, whether performed by in-house auditors or contracted, shared or otherwise) should be driven primarily by a risk-assessment process where the importance of the API to the Pharma company’s business, the nature of the API itself, past experience are some of the items to be evaluated.
Hovione full accepts and complies with the need for audits. A White Paper was issued on this subject and describes how we encourage Clients to visit our sites for face-to-face meetings with as much frequency as possible. However, typical routine Quality System audits need to be reduced in frequency by becoming shared through the use of 3rd party audit program from independent organizations as Rx-360 Consortium .