· 8 min read
In 2021, the world was still under the catastrophic pressure of a pandemic, but it didn’t seem to put a stop to technological advancement. The pharmaceutical industry, especially, has been rapidly launching breakthroughs to fight the pandemic and other diseases. Meanwhile, with traveling and going out limited by the pandemic, I discovered it was the perfect time to equip myself with extra knowledge and skills to grow with our industry.
My enrollment in NSF’s pharmaceutical Qualified Person (QP) courses was a deliberate decision by the No Deviation team, taking into consideration the quality of NSF trainings, the vast array of topics the QP modules cover and, most importantly, my personal development path. Although under Singapore’s regulations, QP responsibilities are not currently required — and it’ll very likely remain this way in the near future — the benefits of acquiring QP knowledge outweigh the need to be QP certified. I was further encouraged by Mr. Sia Chong Hock, Director and Senior Consultant of Singapore’s Health Sciences Authority. “Just go for the knowledge,” he said. I did, and I’ll forever be grateful for his support.
“I took the QP trainings in the midst of a personal career transformation from process engineering to quality and compliance. Not only has my knowledge been tremendously broadened; more importantly, my mindset and way of working have shifted.”
EudraLex, Volume 4, Annex 16, states: “… (T)he QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the (EU) Member State where certification takes places, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).” The huge responsibility of a QP requires them to understand and be able to identify any risks around a medicine’s life cycle, from pharmacology to pharmacovigilance. NSF QP training modules cover the key areas of manufacturing, analysis and testing, pharmaceutical quality systems, higher-level requirements of laws and legislation, and QP responsibilities. They are also supported by the enablers including statistics and pharmacology to better analyze the situation.
I took the QP trainings in the midst of a personal career transformation from process engineering to quality and compliance. Not only has my knowledge been tremendously broadened; more importantly, my mindset and way of working have shifted. Recently, I spoke at the ISPE Facilities of the Future conference about the data mindset and digitalization in the pharma industry, and I was asked if I see myself as an “early adopter” of innovations or part of the “late majority.” I shared my shift from being a “passive adopter” to a “proactive adopter” pre and post QP trainings. Only through understanding the fundamentals of the industry could I better appreciate better why innovation is needed, where it’s needed and how it can help.
In the past year, my learning curve was steep but smooth, with substantial assistance from the QP trainings, which helped connect all the dots. For example, when reviewing an aseptic filling facility layout, I’m able to see beyond the engineering aspects and to link it to future operational procedures, environmental monitoring procedures, contamination control strategy, etc.
There are three main factors that made the NSF QP trainings so effective for me:
Though I’ve completed all the planned QP modules, that’s only a start, as they have inspired me to study more and prepared me with a solid foundation for further learning. 2021 marked one of the critical points in my career, and now I’m ready for a new challenge.