Supply chains were once confined to a single country or continent; as companies seek to source quality goods at the lowest cost, they have stretched around the world . While managers have become skilled at addressing frequent, low-impact incidents such as demand fluctuations or supply delays that affect efficiency, they may struggle with preventing or mitigating the impact of disruptive, unpredictable risks. Furthermore, there is much uncertainty with the timing and magnitude around these risks.
With the Pharmaceutical industry, major threats include theft and fraud. Such high-impact events threaten supply chain integrity and brand reputation. Furthermore, they can have a domino effect on other parts across the globe, affecting stock price, market share, capacity, and more.
How should leaders prepare for disruptive risks while maintaining gains from improved supply chain efficiency?
The Drug Quality and Security Act was signed into enactment on November 27, 2013. Title II of the Act, the Drug Supply Chain Security Act (DSCSA), establishes a national system for tracing pharmaceutical products through the supply chain.
Many pharmaceutical companies have turned their attention to full drug serialization. DSCSA requires manufacturers to mark packages with a product identifier, serial number, lot number, and expiration date by 2017. Serialization will impact all IT operations, from packaging lines through data exchange with trading partners. Given the list of multifaceted complexities involved, the implementation deadline of two years is approaching sooner than you might think.
In that period, highly regulated packaging and distribution processes must be changed; physical equipment must be procured and operationalized; enterprise-wide IT must be implemented; and end-to-end serialization testing must take place well in advance of the deadline to allow time for any necessary adjustments.
As a pharmaceutical company, implementing your serialization infrastructure is first and foremost.
The following are what we believe to be the top challenges which would motivate and justify a serialization journey:
- Isolated Solutions
- Extensive Manual Efforts
- Difficult to comply
To learn how Krypt helped a global Biopharmaceutical company successfully complete their serialization journey, you can read our customer case study.