Analytical Quality by Design Vital to Research in Regulated Industry, Says Expert
A Process Analytical Technology (PAT) specialist, Mr Shemaiah Okeniyi has stressed the importance of Analytical Quality by Design (AQbD) to research for the regulated industry.
Mr Okeniyi, Senior Formulation and Development Officer/Coordinator, Formulation and Development Department, May & Baker Nigeria Plc, was the Guest Speaker at a recent Town and Gown Seminar of the Department of Biochemistry, Covenant University.
While making his presentation titled ‘Laboratory Analysis through Analytical Quality by Design: Making Research Fit for the Regulated Industry’, Mr Okeniyi said AQbD could be achieved by identifying Analytical Target Profile (ATP), selecting suitable analytical method, risk assessment, Method Operable Design Region (MODR), analytical method implementation, and continuous improvement.
Mr Okeniyi noted that Laboratory Analysis was the first step to making sure of the outcome of the research. He stressed that Laboratory Analysis should be followed by the measurement of product performance, which was then quantified under controlled and documented conditions, where performance could be replicated by duplicating those conditions.
He clarified that Quality by Design (QBD) was a systematic approach to development that began with predefined objectives and emphasized product and process understanding and process control, based on sound science and quality risk management.
On the other hand, he described Analytical Quality by Design as the concept of Quality by Design (QBD) applied to analytical method development, which gave room for flexibility, robustness and confidence in an analytical method as long as it was run within its operable design region.
Highlighting the challenges of the profession, the Guest Speaker described the level of regulation in the industry as high and challenging. “Our industry is highly regulated. The regulation is also interested in what and who we work with, has and does. Laboratory Analysis, the centre of discussion, is also regulated,” he stated.
Mr Okeniyi pointed out that one of the ways forward was to apply Analytical Quality by Design. He validated his point with a quote by Dr Joseoh M. Juran: “Most quality crises and problems relate to how a product was designed in the first place. Therefore, quality cannot be tested into the products but quality must be built in by design.”
Earlier in his opening remarks, the Head of Department, Biochemistry, Professor Israel Afolabi, welcomed the Guest Speaker and appreciated his gesture of honouring the invitation of the Department. He also thanked the faculty and staff of the Department for working towards the success of the event.
He appreciated the University Management for conceiving the Town and Gown idea and establishing the platform which, he said, had been a tremendous blessing to the students. He enjoined the students to take full advantage of all that the platform had to offer and especially pay attention to the lecture of the day as they would learn a lot.