As a pharmaceutical manufacturer, dealing with challenges and unexpected issues touching every aspect of the business is likely a day-in-the-life scenario. While tending to the demands of stringent compliance requirements and production schedules, other priorities such as improving process stability, reducing costs and pursuing continuous improvement are also vying for your attention. Everyone in pharmaceutical development can relate. This is why opportunities to exchange ideas and learn from industry colleagues are extremely valuable.
One such event is the 2019 International Society for Pharmaceutical Engineering (ISPE) Annual Meeting and Expo, which will be held Oct. 27-30 in Las Vegas, Nevada. Two presenters in the lineup are Joy Langley, director of operations at Exemplar Compliance and Terrance Holbrook, director of product at MasterControl. Both Joy and Terrance have spent years developing regulated products and contending with the struggles pharma manufacturers experience on a daily basis. Their presentation includes discussions of pharma industry trends and how companies can rein in their challenges while strengthening their relevance and competitive edge by digitizing manufacturing processes.
Pharmaceutical development is experiencing unprecedented changes — particularly in the speed and level of complexity of manufacturing processes. Spoiler alert: technology is the biggest contributor to this transformation.
Single-Use Technology: Streamlining the Supply Chain
Once a disruptive technology, single-use technology is rapidly becoming mainstream in pharma manufacturing. Initially, the concept was developed in response to the industry’s need to:
Single-use technology is economical and efficient because it consumes less water, utilities and chemicals, and it has a smaller carbon footprint then traditional stainless-steel processing. A significant benefit of the technology is it enables manufacturers to improve sterility assurance and quality and develop new therapies more quickly.(1)
Manufacturing Is Becoming Highly Data-Driven
Company business units that were once content to stay on their own turf are discovering the need to share data and exchange notes. The convergence of organizational expertise and data management is becoming a mandatory component of business strategies. The upside is it presents a tremendous competitive advantage by fostering more company wide transparency and collaboration.
More Data From More Resources
Pharmaceutical companies rely heavily on clean, up-to-date and relevant data. This is necessary for staying informed of industry and regulatory trends, developing strategies and making the best possible decisions.
Advancing technologies are making data more abundant and more focus area-specific. Manufacturing equipment with multiple data gathering sensors is capable of generating upwards of 10 GB of data per second. This concept, referred to as big data, is effectively transforming pharmaceutical development and product life cycle oversight. Still, having access to tons of data can be useful, but what do you do with it? It’s critical to have processes and tools in place for mining, analyzing and consuming data obtained from multiple sources. Otherwise, a lot of valuable data will be left on the table.
No pharmaceutical manufacturing pathway is complete without a few hurdles, road hazards and detours — not to mention the consumption of enormous amounts of time and money. The ranking priorities tend to include getting products out the door on schedule, making sure products don’t come back, and keeping budgets intact along the way. Still, seemingly small hurdles can escalate into compliance issues that can stall production, adding more strain to already tight schedules and budgets.
The Nature of (Any) Business
There is a common perception that some manufacturing obstacles just come with the territory of business operations, regardless of the industry or product, these might include:
These issues aren’t always show stoppers, but they can make production processes more cumbersome and costly.
Mountains of Paper
“Mistakes are the portals of discovery.” - James Joyce
Apparently, Joyce never tried to get a regulated product approved and on the market. Manufacturing any product typically involves paper — and lots of it. This means mistakes, quality issues and shipment delays are almost guaranteed. Despite this trend, paper-based systems still seem to be popular in pharma manufacturing.
Here are just a few of the headaches brought on by using paper-based processes:
To benefit from the emerging trend of business unit convergence, companies need a way to actually converge. Unfortunately, businesses using function-specific business and operations management systems remain siloed and unable to share data because it is scattered across different databases, spreadsheets and printed records. Under these circumstances, data is often incomplete or inaccurate, which can lead to costly errors and oversights.
There is no reason to continue trudging through production processes and getting tripped up by unforeseen obstacles. A few tactics that companies can implement across their organizations to keep production on schedule include:
These methods certainly qualify as a strategy for improving operational performance and productivity. Another strategy would be to give technology a chance.
Digital technology is characterized by the interconnectivity of computing devices, machines, systems and people. Solutions currently exist that can gather and analyze enormous amounts of data in less time than it takes to set up a new spreadsheet. Departmental stakeholders can instantly retrieve the most up-to-date, focus area-specific data to perform predictive analytics with a high level of accuracy. Smart mobile devices that make it nearly impossible to make a mistake are replacing paper reports on the shop floor.
At the component level, here are some of the key technologies used in manufacturing environments:
Quality at the Source
Taking a tip from lean manufacturing practices, the core principle of lean is reducing non-value adding activities and waste. Any task completed outside of an established process is an added cost. Even though quality management is a regulatory requirement, it is often tacked on at the end of production. This makes it an added process, and hence, an added expense.
Ideally, quality and manufacturing should be joined at the hip instead of having their own agendas and priorities. Implementing quality assurance procedures at each phase of the production line minimizes errors and avoids the need for a costly add-on process.
A basic principle of digital technology is that connecting systems and machines creates intelligent networks and automates manufacturing processes throughout the supply chain. That said, phasing out paper-based processes is actually becoming more of a necessity than an option. Otherwise, as technology continues to evolve, plodding through manual processes will undermine your ability to keep pace with the industry.
Single-Use Technologies Transform Biopharmaceutical Facilities and Manufacturing Equipment, PharmTech, July 19, 2017 http://www.pharmtech.com/single-use-technologies-transform-biopharmaceutical-facilities-and-manufacturing-equipment
David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.