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Quality at IBSA: the aim and the requirement for teamwork

17 December 2020

Conversation with Andreas Bernd Gerber, Head of Quality Assurance

The real challenge IBSA faces every day is to maintain a very high level of quality over time. For the company, quality is one of the main assets of its business and is part of the company culture. It offers added value, making it an investment rather than a cost. This is why the Quality Assurance department has steadily grown over the years to its current staff of 25, led by Andreas Bernd Gerber, who is here to talk to us about the subject.

“The department’s growth is due to the growth and internationalisation of IBSA as a company. Attention to quality means for us creating the basis for developing and selling our products around the world by meeting global regulatory and medical requirements. It is well known that IBSA’s products are innovative and safe for patients. In order to be able to market them as such, very robust processes demonstrating their quality are required. This is why we conduct an average of 6-7 inspections a year. Only through constant controls can we have the certainty of launching a new product on a new market or on a market in which we already have a presence, or of maintaining the authorisations already granted. There are always lessons to be learnt from inspections and they thus help the company grow.”

Over the years, IBSA has developed what has proved to be a winning technique: “The Quality Assurance department prepares and coordinates inspections following a structured and defined process involving a multi-disciplinary team made up of individuals who are prepared to meet the challenge with enthusiasm. It is people who really make the difference in this process. For us, quality is fundamental and it’s crucial to educate and disseminate information about quality aspects, raising everyone’s awareness. At IBSA, it’s neither quality control nor quality insurance that makes quality, but every single person in the company who contributes their work to the final result. Our supply chain also has a very complex structure. Manufacturing raw materials and semi-finished products abroad means relating to different cultures while continuing to follow the IBSA philosophy.”

How have IBSA audits evolved over time and how has the approach changed in line with experience?

“In the first few years of the new century, each inspection was an event with a direct impact on company operations. Today, through great organisation and professionalism, and having developed a habit of handling inspections, they are now part of daily activities and no longer slow down operations. In recent months, with the COVID-19 pandemic, we have had to change our procedures and our approach to inspections, moving from site inspections to remote inspections. From one day to the next, it became impossible to conduct physical inspections on-site. This led us to reflect on how we could arrange inspections differently and, as is in IBSA’s DNA, the company was ready to innovate to continue to allow all the necessary quality controls to be conducted with new approaches.”

Quality assurance offers assurance to all departments. What does it mean for the IBSA quality assurance team to be responsible for the company’s main asset and how do you prepare for audits on a daily basis?

“The best possible preparation requires continuous process improvement in order to guarantee high product quality and, consequently, safe drugs for patients. At the same time, it requires rational and efficient integration of new directives and requirements, in line with the provisions set forth by the authorities. This all allows us to conduct inspections as efficiently as possible, even if, as with all events, it has required focused effort in recent weeks. It’s also key to see inspections as an opportunity to grow.”

What does it mean for IBSA to be a quality company and how does the social responsibility of caring for people and their health materialise in each individual’s work within the company?

“We each have a lot of tasks and targets, from the purchase of components to the sale of drugs, from the development of analytical methods to the maintenance of machinery, from communication to the labelling of goods in stock, to name but a few of the main activities that take place at IBSA. A lot of hard work and sweat, with a common thinking behind it all: to provide quality products that improve everyone’s lives. We thus make our small contribution to making those in need feel better. For me, this is an incredibly beautiful and fascinating aspect of our profession: being able to help others.”

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