Over 10 years experience of Traceability Solutions
By Pharmatrax Author
Category: Technoloy
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Emerging technologies can make quality control (QC) faster and more efficient. What do pharma companies need to do to become QC leaders?
he emerging technologies that characterize Industry 4.0—from connectivity to advanced analytics, robotics and automation—have the potential to revolutionize every element of pharma-manufacturing labs within the next five to ten years. The first real-life use cases have delivered 30 to 40 percent increases in productivity within already mature and efficient lab environments, and a full range of improvements could lead to reductions of more than 50 percent in overall quality-control costs. Digitization and automation will also ensure better quality and compliance by reducing manual errors and variability, as well as allowing faster and effective resolution of problems. Use cases have demonstrated more than 65 percent reduction in deviations and over 90 percent faster closure times. Prevention of major compliance issues can in itself be worth millions in cost savings. Furthermore, improved agility and shorter testing time can reduce QC-lab lead times by 60 to 70 percent and eventually lead to real-time releases.
While most of the advanced technologies already exist today, few pharmaceutical companies have seen any significant benefits yet. On one side, quality leaders often struggle to define a clear business case for the technological changes, which makes it difficult for them to convince senior management that lab digitization or automation can deliver significant impact. On the other side, companies rarely develop a clear long-term lab-evolution strategy and blueprint, which can lead to some costly investments with unclear benefits. For example, many companies have already taken steps to become paperless by first simplifying paper records to minimize the number of entries and then digitizing lab testing records. Now those moves are being superseded by new advances in equipment connectivity that enable direct transcription of thousands of data points without any manual data transcription and without any reviews.
To capture opportunities offered by existing and emerging technological advances, companies should set clear goals, define robust business cases for any level of investment, and engage in rapid piloting of the new technologies followed by fast scale-up of pilots that deliver promising results. To succeed in the future, pharma companies need both the foresight to make long-term strategic investments, including those in R&D for developing and filing new test methods, and the agility to adapt those plans as technologies rapidly evolve.
Multiple digital and automation technologies have created opportunities for change in pharmaceutical laboratories. Most pharma labs have not yet achieved digital transformation, but labs can aim for one of the three future horizons of technological evolution (Exhibit 1).
Digitally enabled labs achieve at least 80 percent paperless operations. These labs transition from manual data transcription and second-person verification to automatic data transcription between equipment and the general laboratory information-management system (GLIMS).
Digitally enabled labs use advanced real-time data analytics and ongoing process verification to track trends, prevent deviations or out-of-specifications, and optimize scheduling. They employ digital tools like smart glasses to translate standard operating procedures into step-by-step visual guidance on how execute a process. They create a digital twin of a lab to predict impacts before making physical changes. All these are currently available technologies, with time to impact as short as three months for each case.
An average chemical QC lab can reduce costs by 25 to 45 percent by reaching the digitally enabled lab horizon. Potential savings at an average microbiology lab would be in the 15 to 35 percent range. Productivity improvements come from two main sources:
With fewer manual errors and data-enabled analyses of root causes, labs can reduce investigation workloads by as much as 90 percent.
Digitally enabled labs also reap compliance-improvement benefits from reduced errors and variability, as well as seamless data retrieval and analysis. The increased productivity and scheduling agility can also reduce lab lead time1 by 10 to 20 percent.
One large global pharma company transitioned to a digitally enabled lab within its Italian digital lighthouse plant. Lab productivity at the site jumped by more than 30 percent after the company implemented advanced schedule optimization by harnessing a modular and scalable digital-twin platform adapted to the lab-specific scheduling constraints. The site also used advanced analytics to reduce deviations by 80 percent, eliminating reoccurring deviations altogether and accelerating deviation closure by 90 percent.
Pharma companies have many options when it comes to choosing and customizing technological solutions to create digitally enabled labs. In addition to custom digital-twin and advanced-analytics platforms, other solutions include real-time insights from IoT platforms such as ThingWorx, lab scheduling software such as Bookitlab or Smart-QC, and digital assistants with visual operating procedures from providers such as Tulip.