Mr. Fabio on GMP Compliance, Quality Systems & Inspection Readiness in Pharma

Pharma Now: You have worked across pharmaceutical manufacturing, consulting, and quality leadership roles. What key experiences shaped your journey in quality and compliance? 

Mr. Fabio: I worked for pharmaceutical companies, in QA roles, before my experience as consultant. This was very important to learn from inside how the pharma companies work and so, to provide the right advices/recommendations as consultant.

During these working years, I've been lucky to learn and collaborate with very good bosses, masters and professionals, so to learn properly the best way to implement and manage GMP quality systems.

I've been working with big pharma, as well as small companies, so I learned the necessary flexibility and different challenges between big and small companies.

Over the years you have moved from quality system roles to advising companies at a strategic level. What motivated that transition toward consulting and executive advisory? My continue will to learn more and to be involved in new interesting projects, as well as to be in touch with people. For this reason, I think that consultancy roles are the best for me.

In the last years I've been able to make my Business Unit and consultancy companies grow, as well as to create good groups of colleagues and collaborators. I consider this a great experience and result for me.

Pharma Now: Having worked across multiple organizations and regulatory environments, what early lessons helped you build expertise in GMP compliance and validation?

Mr. Fabio: My previous experience in pharma companies in QA roles, both in small and big organization, helped me a lot to later work as a consultant. When you work inside an organization, you can learn important aspects and process flows which are absolutely recommended to act as a consultant.

I've been involved in consultancy projects and audits across the globe, this permitted me to learn from each plant and country visited in my work experience.

Pharma Now: At the Pharma and Biotech Quality Summit, quality leaders will discuss modern compliance challenges. From your perspective, what are the most pressing issues facing quality teams today?  

Mr. Fabio: The continue update of GMP regulations, stricter every time, is a challenge for pharma companies, that need to implement and maintain robust QMS to face all the necessary requirements. The pharma world is evolving very fast, which computerised systems, digitalization and AI progressively substituting the old paper-based QMS. The Quality Unit and Companies must adapt to these new realities. 

You will be speaking at the summit. What key message or insight are you most looking forward to sharing with the audience?

Be positively curious and proactive about GMP requirements and trends. We can learn a lot.

Work in Team, always.  

When possible, focus on lean systems and process control and process knowledge. Apply the proper QRM tools.

Errors happen, but recurrence is the devil and must be avoided!

Pharma Now: As someone who audits and advises multiple organizations, what common quality culture gaps do you see across pharmaceutical companies?  

Mr. Fabio: Lack of proper communications, in data and processes, is probably the most common gap and point for improvement in the companies. Some companies face also challenges related to old equipment and systems, modern systems and technology can help a lot, but it can be expensive and must be implemented and introduced in the companies in a proper way.

Pharma Now: How can companies build stronger inspection readiness in an environment where regulatory expectations are constantly evolving?  

Mr. Fabio: Working in Team, looking for correct QMS flows and eventual gaps and delays and bottle necks in the activities (trying to solve them), be always transparent and proactive with auditors, looking for continuous improvement and avoiding recurrence in deviations and errors (finding the root causes and implementing proper CAPAs). 

Pharma Now: What practical steps should quality leaders take to ensure their organizations remain compliant while still enabling innovation?

Mr. Fabio: Being always deep involved in the companies flows, collaborating with all departments. Always trying to reduce gaps and bottle necks and looking for continuous improvement. Personnel training is also really very important.

Rapid-Fire Round

Pharma Now: Quality culture in one word

Mr. Fabio: Data integrity and reliable processes   

Pharma Now: Most important GMP principle

Mr. Fabio: Process knowledge

Pharma Now: Biggest misconception about compliance teams

Mr. Fabio: Compliance is not something theoretical, but it must be practical, really applied in organizations and manufacturing plants

Pharma Now: One skill every quality leader should develop

Mr. Fabio: Communication and listening

Pharma Now: How would you describe AI in pharma quality in one sentence?

Mr. Fabio: Powerful tool for managing big and complex data