In the pharmaceutical manufacturing industry, both the drug manufacturing process and the plant production environment are highly regulated to ensure product quality and safety.
Constant environmental monitoring is a strict requirement of GMP/FDA regulations. Falling out of compliance can mean the loss of a drug batch worth millions of dollars and delays in drug availability for patients.
At the same time, pharmaceutical insiders know that the rate of increase in demand for manufacturing has outstripped the industry’s current capacity — as well as traditional means of increasing capacity. Big Pharma is looking for new strategies to increase productivity that are required to achieve a variety of pressing goals.
These goals include increasing the number of biologic drugs in development, meeting the global need for the COVID vaccine, and addressing the new remote work paradigm created by this virus. Pharmaceutical leaders are actively seeking ways to increase quality and efficiency while reducing human interaction at plant sites.
One answer has been the acceleration of digital technologies. The adoption of Industry 4.0 technologies is gaining new momentum and is pushing Big Pharma compliance to move from paper to digital systems — for good reason.
Every year thousands of new drugs are proposed to the FDA and only average about a 10% approval rate. Meanwhile, the cost for bringing a new drug to market is just below $1 billion. Regulators and QA departments require extensive testing data during the production of a given drug and pitfalls during this collection process are costly and time-consuming.
Pharmaceutical leaders are aware of the need to digitize their systems for this process. But not all of the data they are considering digitizing has equal value. Some are especially hard to get — referred to as “environmental data”, which relies on precise measurement devices to prove the safety of production environments. Environmental data measures the real-time impact of environmental conditions on the efficacy and safety of a drug being manufactured.
At the moment, most of Big Pharma acquires this type of data by hiring experienced lab technicians. While these workers may be expensive, they have a mission-critical function: flawlessly operating a variety of measurement devices to ensure compliance.
Without lab technicians pulling daily data from particle counters, pH meters, osmometers, and a variety of other lab instruments, Pharma regulation would collapse. Any executive from the pharmaceutical space knows just how painful FDA fines or a production stoppage from reporting errors can be. These lab instruments are also used to achieve the “Good Manufacturing Practice” certification which is critical to FDA approval.
This painful process is one of the main reasons why Pharma is shaping into an ideal digitization and automation industry. It is exactly this type of repetitive, expensive compliance testing that costs the biggest pharmaceutical manufacturers hundreds of millions annually. Current Pharma compliance slows the industry’s production capacity, is prone to human error, and is an inefficient use of valuable lab technician resources.
The second reason for Pharma to digitize is speed-to-market. Being able to operate lab instruments remotely saves money and normalizes data so that it can be quickly integrated into lab information systems, dramatically improving the rate of discovery.
An automated compliance solution allows valuable lab workers to focus on their core goals: discovery and production, not operating testing devices.
The key to Pharma automation is digitizing the industry’s variety of measurement devices themselves. Connecting these complex devices to a unified platform is what truly constitutes the ideal IoT automation solution for end-users.
Automation in this case means that lab technicians will have the ability to view, verify, and run their environmental testing remotely. It is an upgrade to the pharma testing process commensurate with the industry’s stunning innovations on its medical side. Fortune 100 Companies have seen lab technician fees reduced by 35% by trusting these rote and repeat processes to remote operations. In doing so, more resources can then be made available to invest in life-saving treatments like COVID vaccines.
In this instance, automation technology allows for the complete standardization of testing — and this consistency is the most important part of verifying consistent and auditable records. This type of digitization and automation is already changing the way that lab technicians operate the Pharma compliance process.
Until now, most automation use cases for IoT have focused on relatively simple functions for single machine types. This mission-critical compliance data and IoT case make a perfect fit between technology and mission. It is why automation is particularly important for pharma: to meet the increasing and critical demands on the global pharmaceutical industry, the future is multi-device, multi-vendor automation for the space.
Ben Davis, Phizzle CEO