Crazy About Quality and Compliance?

Michalle Adkins is Emerson’s director of life sciences consulting, and in that role she draws on her years of working in the pharmaceutical manufacturing to help guide customers and make sure Emerson has the products necessary to support this complex and critical industry.


Michalle AdkinsIn the June 2017 issue of Pharmaceutical Manufacturing, her column discusses what is necessary for effective and efficient manufacturing in this tightly regulated environment:


Have you ever stopped to ponder how many things can go wrong during the planning, manufacturing, testing, reviewing, releasing and storage of a batch? Thinking back to my production management experience at a pharmaceutical manufacturer, I can recall my own amazement at the number of things that could and did go wrong, even when the production process was supposedly fully automated.


Her experience says the truly successful manufacturers got that way because this is what they set out to become. There is an intentionality required to become good manufacturers, it doesn’t happen by chance or through trial-and-error.


Do you think this may be why we hear so much about data integrity, data analytics, continued process verification, PAT, electronic batch records, electronic log books and predictive analytics? These are not just buzzwords, but are several of the right-first-time or compliance enablers used to produce beneficial products that ultimately improve the global quality of life — yours and mine. Taking a multi-dimensional view of successful organizations, there are many places to build in compliance enablers. Starting in the pipeline process from R&D to commercial manufacturing, here are some of these enablers: build process understanding, design capable processes, and deliver appropriate controls. Design of experiments and PAT are also important pieces of this process. In addition, tools enabling process control, product data collection and recipe management across the product lifecycle are pertinent as well.


Did you spot three key points? “Build process understanding, design capable processes, and deliver appropriate controls.” Build, design, deliver. That’s intentionality. There are many tools available to support such an effort.


Reliable flow, temperature and pressure instruments provide insight into the process. Analyzers verify product composition and quality. Automation systems and actuators act on these measurements to control the process. Diagnostics, predictive sensing, process analytics, electronic batch records, electronic log books, process verification tools and predictive reliability tools enable right-first-time manufacturing.


There it is: the right tools used with the right strategy. How do you make it happen in the real world? Part of it might be to reach out with people who’ve been successful, and one place to look for them is the Emerson Exchange365 community. Here you can meet veterans like Michalle and others like yourself who are looking for answers and willing to share experiences. There are special areas such as Pressure or Temperature, but also quite a bit looking at specific industries and applications, such as pharmaceuticals. Come join the discussion with your peers and experts.