I’ve discussed some of the new regulations facing the pharmaceutical industry in past posts. Some of these regulations, like data integrity, are relatively consistent across the globe while others, like serialization requirements, vary greatly from country to country. Of all the challenges companies face in their quest for globalization, the lack of harmonized regulatory requirements they face can be the biggest obstacle.
How do pharmaceutical companies balance these requirements with the need to have a flexible supply chain? The emergence of large economies like China and India, aging and shifting populations, and personalized medicine are all contributing to the need for a more globalized and flexible supply chain.
To meet these demands, companies are more frequently looking to transform their operations by implementing digital batch management. This transformation provides both the regulatory consistency and the flexibility that have in the past been opposing concepts in the pharmaceutical industry. Now more than ever, digital transformation can be the driver of both compliance and flexibility.
To learn more, download ARC’s whitepaper on Smart Manufacturing in the Life Sciences
Consistent operations drive regulatory compliance
In the past 20 years, pharmaceutical companies have evolved from having blockbuster drugs manufactured at dedicated facilities towards diverse, multi-product facilities across the supply chain. 3rd party manufacturing sites have also been normalized as part of the global network.
While this new direction has created needed flexibility in meeting shifting demands, it has also prompted regulatory bodies to question the consistency of quality for drugs being sold under a single brand name. How does a pharmaceutical company prove that a product being produced at several facilities is meeting the same strict requirements for each?
More companies are turning to digital batch management to ensure this consistency. Ideally, each facility would operate from a single master recipe for each product. This would assure regulatory bodies that there is total consistency from site to site. The reality is that there are several challenges with reaching this state because of the mix of internally and externally owned facilities all of which may be multiple product facilities with no strategy for standardization of processes. This lack of standardization hampers the ability of pharmaceutical manufactures to easily move production within their manufacturing network, and can add considerable time and cost in bringing products to market.
A two phased approach is best for addressing this goal. At the plant level, a single communication layer is required to accept the global recipe. At the global level, a single recipe is created from the diverse recipes of each plant. This is no easy task, but this undertaking ensures the ability to continue to manufacture across the diverse supply chain and achieve maximum flexibility.
Flexibility is the goal
As I stated, the changing global manufacturing networks are driving the need to have a wide spread and diverse supply chain. Not only does this flexibility help to meet changing long term demands, but it can help to mitigate the risks from natural disaster, cyber-attacks and other unexpected events. The ability to temporarily shift production to a sister facility allows companies to avoid shortages of critical and life-saving therapies that patients rely upon.
An added advantage of flexible operations is a faster time to market for new drugs. Limited patent protections drive an urgency for getting newly approved products on the market. Digital operations allow for new product introductions and product changes with significantly faster regulatory approvals. This maximizes the time on the market and increases market share for the company.
To learn more about the benefits of digital batch management, come to Innovation Summit: Software Conference to see this solution firsthand.
Have you digitalized batch processes? What benefits have you seen? Let us know your thoughts in the comments