65.2% of Pharma Professionals Need Clarity on PAT and QbD Regulation Submissions

Andrea Charles


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Whilst companies seek to embed Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives into their wider business to increase product quality and process efficiency, many still face uncertainty with regards to the regulatory review process.

Regulatory uncertainty

A recent Pharma IQ survey conducted on behalf of the 8th Annual PAT and Quality by Design with key members of the community revealed that 65.2 percent of PAT and QbD  professionals think more clarification is required regarding PAT and QbD regulation submissions and that only 13.3 percent of participants have successfully filed using the principles of PAT and QbD.  

Investment in process and operational excellence

These regulatory challenges however do not seem to be deterring companies from investing in process analytical technologies. “The benefits of implementing PAT will not be dramatic in the short term. It is an essential investment for companies that seek continuous quality improvements and sustainable development over a long-term period,” said Rajabahadur V Arcot and Piyush Dewangan from the ARC Advisory Group, in Process Analytical Technology Helps Pharmaceutical Companies Capture Process Knowledge and Achieve Operational Excellence.

Many companies already recognise the benefits of PAT to help them achieve process control and increase product quality. 

In a recent Pharma IQ interview about the effects of applying PAT to pharmaceutical manufacturing and PAT validation, Martin Warman, scientific fellow, analytical development ,Vertex Pharmaceuticals said: “The number one impact is much more robust processes, not only is there a great control over variation, causes of variation. It actually means we have a degree of understanding in the process, parameters and the impact on the product”.

PAT is helping companies to attain their QbD goals, as the study revealed 25.6 percent of survey participants are already actively applying PAT tools and QbD principles to multiple products and 15.6 percent are applying PAT tools and QbD principles to one product.

According to Frost & Sullivan report entitled World Process Analytical Instrumentation Markets: “The pharmaceutical industry's process analytical technology (PAT) initiative and global green environment initiatives supported by regulations are poised to drive the demand for process analytical instruments in the next couple of years.”

“The competition in the total process analytical instrumentation market is intense, with large conglomerates competing with niche market participants. Multinational participants account for more than half the share in this market,” said the report

Greater QbD adoption

The industry is also poised for greater QbD adoption. Nearly 70 percent of the survey participants said that their company had a specific change management strategy in place for better QbD adoption throughout the company. QbD is also receiving attention from regulatory bodies such as the FDA and EMEA who are now actively seeking applications with QbD concepts. Successful communication between both parties will be key for the success of QbD implementation.