DRUG SERIALIZATION

IT’S TIME TO INVEST IN SERIALIZATION!

CHUCK SAILER Written by CHUCK SAILER
29/06/2016

Not having a serialization solution, or a solid strategy for serialization, puts your organization at a dangerous competitive disadvantage.

Keep your competitive advantage – serialize now

For many reasons, serialization within the pharmaceutical supply chain is absolutely essential. Arguably, chief among these reasons, are compliance laws imposed by various governments that help ensure public safety. Not to mention, the widespread adoption of serialization at every level of the supply chain. Serialization is a complex problem, not only in the pharmaceutical industry. With complexity comes risk and uncertainty. The window to identify and mitigate risks and gain clarity on uncertainties is shrinking as mandated deadlines draw near. Not having a serialization solution, or a solid strategy for serialization, puts your organization at a dangerous competitive disadvantage. Trading partners, pharma companies and medical laboratories look for partners who have adopted serialization. If there is an absence of a serialization strategy within your organization, you will miss sales opportunities!

Laws enacted by new countries governing target markets are emerging rapidly. If your organization already has a serialization strategy, you are in better shape than those who do not; however, your organization is not insulated from the fact that laws in known markets evolve and change over time.

If you haven’t done so, the time to invest in serialization is now.

Fighting falsified medicines with serial numbers

Prior to serialization, only the ownership and identity of a product were known. This made it easy for nefarious actors to steal, contaminate, or counterfeit products, which, in case of drugs and medicines, can be deadly for the end customer. Also, prior to serialization, product recalls for any reason, were difficult, error prone, and costly. With serialization, comes an essential data point to help recover from and even prevent costly packaging and/or distribution mistakes.

That data point? The Serial Number!

Coupling the serial number with the existing company and product information, e.g. a Company Prefix and Item Reference – as in the case of a GTIN-14, serialization makes it possible to identify and pinpoint an exact, individual item or conveyance. Additionally, the serial number helps establish a traceable chain-of-custody for a given product.

In short, the concept and practice of serializing products is part of a bigger, overall strategy of anti-counterfeiting, theft prevention, brand protection (and consumer protection in case of pharmaceutical products) and providing visibility of products as they move from point-to-point within the supply chain.

The importance of a holistic serialization strategy

The term “implement serialization” is a bit misleading. This industry misnomer often supposes “implementing serialization” is a packaging line-only problem. Serialization at the packaging line is certainly part of the solution. However, it is by no means a comprehensive one.

To have an effective strategy for serialization, that strategy must have a holistic approach. An effective strategy for serialization must take into consideration that the product itself is not the only thing being “shipped”. Data describing the product is also being moved through the supply chain.

Track & Trace all through the supply chain

Therefore, serialization alone is not enough to deter or prevent supply chain mishaps. Serialization must be used in conjunction with Track and Trace. Together, Serialization and Track and Trace provide valuable protection and insight of products within the supply chain.

Conducting targeted recalls, preventing diversion and counterfeiting, and providing a level of real-time visibility into the supply chain, across vendor boundaries, is all possible with the help of Track, Trace, and Serialization.

From manufacturing to dispensation, these three functions will help assure product safety and product integrity. As stated, this is a complex problem. For example, the data describing the product have requirements for creation, management, storage, and retrieval from either an internal or external data source. Each one of these requirements poses a new set of challenges.

Qualified vendors and solution partners key to successful serialization implementation

If you do not have a serialization strategy or are in the midst of coming up with such a strategy, your best bet is to consult with a qualified vendor. The most important attributes to seek in a vendor is industry knowledge and experience. Select vendors that know it is against your best interests to offer your organization an array of software products and services that attempt to solve problems that you do not have.

Buying into this very prevalent practice only ensures that these vendors will create more problems than they will solve.

The best advice you can be given is that while track and trace and serialization are not trivial in their solutions, the complexity can be reduced by implementing track, trace, and/or serialization in manageable phases, solving only those problems that require solving. Approaches that overreach or attempt to predict future problems are, more often than not, both costly and ineffective with huge impact on OEE and line productivity.

The benefits of drug serialization and track & trace

It is not all about investment and spending money: drug serialization, in combination with track & trace, can have huge benefits beyond compliance:

  • optimizing the supply chain
  • facilitating product recalls
  • fighting grey markets
  • protecting your brand
  • connecting with customers and patients
  • and many more

 

Watch the video to find out more

 

CHUCK SAILER
CHUCK SAILER

Chuck Sailer is an architect, developer, and project leader with notable success in designing, developing, and implementing all facets of world-class, commercial software within a broad range of industries and technologies. Chuck recently joined the Adents team and will be a regular contributor to thought leadership pieces and blogs.

DISCOVER MORE ...

Serialization, aggregation, coding formats – global challenges for the Pharma industry
Serialization, aggregation, coding formats – global challenges for the Pharma industry
With more than 40 legislations in place or to come, compliance is becoming more and more challenging for pharmaceutical companies: different deadlines, different serialization-, aggregation- and coding requirements, suspended and changing directives.
Enforcement sanctions of DSCSA postponed –  opportunity to go beyond compliance
Enforcement sanctions of DSCSA postponed – opportunity to go beyond compliance
The US Food and Drug Administration (FDA) seems to be willing to give the pharmaceutical industry an additional grace period concerning the DSCSA.