Best Practice Ways to Overcome Common Challenges in PAT

Helen Winsor


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Rakhi Baj, Technical Project Leader at Abbott Diagnostics, joins Pharma IQ to offer some best practice ways to overcome common challenges in PAT. To listen to the podcast now go to Inside Tips on Making Progress in PAT.

Pharma IQ: What do you think are the major challenges that hinder the progress of increased process understanding and control?

R Baj: One of the key challenges that I come across quite often is a lack of understanding of the actual tools. People are inherently wary of mathematics and statistics and they get the perception that they’re really difficult and that really it should be left up to the statisticians to work away in the corner and come up with the answer. But I think both scientists and statisticians need to work together to get a better understanding of the process; what are the issues; where are the bottlenecks, and then decide on the best approach. I think it’s really important for statisticians to get a better understanding of the process and for scientists to get a better understanding of statistics, and that way the two groups can decide on the best tools to use for that specific area.

Pharma IQ: So, expanding on this, do these challenges differ when working in the diagnostics field, and if so, how?

R Baj: Not really. The challenges stay the same, but the processes are different, but I do believe that with increased communication and working across the functional groups, a better understanding of the process can be achieved, and therefore better control.

Pharma IQ: Finally, what are the key tools and techniques that you personally find the most effective in your work?

R Baj: In terms of the statistics tools we use a lot of control charts and host capability type tools and indices, and in terms of the non-stats tools, things like process flow diagrams and Ishikawa fishbone diagrams work really well. We’re big fans of fast jump and mini tab as well in terms of statistical software packages and we use them quite a lot in everyday activities.

Pharma IQ: And just to round us off, you’re going to be delivering a presentation at the PAT and QbD conference. What is going to be the key learning lesson that you’ll be offering at the event?

R Baj: I hope the people will get an appreciation of what we do at a diagnostic plant, and the kinds of challenges that we’re facing in terms of using these quality control charts and quality control process capability type tools and things like that, and how we’ve implemented them into the culture of the organisation. So I hope they get away with a sense of appreciation of what we’re trying to achieve on the site.

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