Technological Critical Success Factors (CSF) of Serialization that Add Value to the Pharma Supply Chain

We’ve known serialization since 2013 when it was first mentioned in the DSCSA regulations, outlining the requirements of a pharma supply chain that is not just complaisant, but also counterfeit-free. While complaisance is straightforward and technical, which is made up of factors that streamline a supply chain and makes it effective in its functioning, the term ‘counterfeit-free’, however, holds a lot of meaning- fundamental, practical and technical. These three elements hold the key to the supply chain and apply to all the complaisance phases of it, including Serialization.

We have spoken enough in favor of Serialization and how it dis-entangles the supply chain, ensuring that each of the products in the supply line is visible. And, what is the key to the process? The 3-point thumb rule we’ve mentioned in the first paragraph, which inadvertently determines the CSFs of the Serialization process.

We will not go into the benefits or challenges of Serialization since you can find them in the following articles:

[Serialization 2.0: Are you prepared for it?]

[Hierarchical Data: Defining the Cases in Aggregation Serialization]

But, we will focus solely on the success factors of the process. Why serialization? You may ask. The answer lies in the DSCSA requirements and timeline, which is:

January 1st, 2015

Lot Traceability: All pharmaceutical manufacturers were required to print lot numbers on the packaging for all prescription drugs.

For: Manufacturers, Distributors, Repackagers,  Dispensers

November 27, 2018

Serialization: All pharmaceutical manufacturers and repackagers were required to include unique serial numbers and expiration dates on prescription drug packaging.

For: Manufacturers, Repackagers

November 27, 2019

Serial Verification: All pharmaceutical wholesale distributors were required to verify the product identifier during the saleable returns process.

For: Distributors

November 27, 2020 (postponed to 2023)

Serial Verification: All pharmaceutical dispensers are required to authenticate and verify the drugs they buy before selling them to the end-users.

For: Dispensers

November 27, 2023

Interoperability: The final compliance standard that encapsulates all the above requirements, demanding the entire supply chain be DSCSA compliant. Complete unit-level traceability, including aggregation, will be mandatory.

For: Manufacturers, Distributors, Repackagers, Dispensers

The pattern is clear and vivid. The terms ‘serial numbers’ ‘serialization’ appear so frequently, you are forced to re-think the emphasis DSCSA lays on the process.

Going by the elements:

Fundamental: We will check if the process of serialization carries the sentiment of the DSCSA regulations. Close to 60% of the drugs being circulated in the world are fake, victimizing innocent lives, sometimes leading to death. The cost of these lives add up to more than $200 billion and counting by the year. The DSCSA regulations were outlined to ensure that such spurious practices stopped and precious lives preserved. In this article, we will check if the serialization practices adopted by supply chain stakeholders adhere to the basic requirement of eliminating the counterfeit drugs.

Technical: What practices or technological adoptions are being done to ensure that the above-mentioned sentiments are not achieved at the cost of huge capital investments, which might sometimes oust the smaller pharmaceutical players in the market. Having said that, we will also explore the technological possibilities that can be adopted to enhance traceability by notches.

Practical: In the United States, it takes close to 12 years for a medicine to reach its end-users right from the day it has been conceptualized to the time it reaches the end-users. The purpose of the medicine jeopardized to some extent after all these years. Drug delivery delays are often mired by long-hauled processes of validation that require prolonged labour-intensive hours, only adding to the capital investment of companies in the Big Pharma, thus raising the price of the medicines inadvertently. So, we will explore the measures and practices that can make a serialization process effective, efficient and time-bound.

Detailing the CSFs

Eliminating the counterfeit and more: Packaged serialization now provides brand owners with increased security and protection from counterfeiting and enhancing traceability. But it is not restricted to doing so and also promises of supply chain efficiency and returns management (VRS).

The technical supremacy: Serialization is a multi-layered process which includes packaging drug units with serial numbers that are both human and machine-readable. These could be 2D or Datamatrix codes that can be easily scanned with a machine. These unique serialized codes are then uploaded to a secured data repository that can be accessed by various parties, including pharmacists, law enforcement officials and even consumers. It needs to be mentioned here that individual packages can be aggregated here maintaining a parent-child relationship. As a result, if the bar code on the pallet is scanned by a warehouse manager, he gets to know the content of the package immediately. In other words, the brand owner or the trading partner will have tracking information regarding all shipping containers and primary containers at the warehouse. This minuscule-level serialization is gaining popularity because of its error-free tracking results that also help in improving the VRS process.

Practical: Right now, the pharma industry is gearing up to the advancement in technology such as AR-enabled multiscanners and insta-verification software. However, only 52% of the stakeholders in the pharma industry are keen on these pieces of equipment because of the investment required for deploying these technologies. As a result, most of them are still stuck to using humans, instead of machines, to authenticate a drug package by opening individual units and checking the content. Imagine the time required to handle bulk consignments in this way. Least said it is neither practical nor time-bound. The drug industry, as already mentioned is slow in meeting the needs of the end-users. Lack of involvement of machines will further hold the process back.

[Read about Aggregation and unit-level serialization here]

Improving the CSFs

The pharmaceutical industry requires a solid technological base, right from testing the medicine in the lab to producing in the manufacturing unit. The individual phases of traceability, including serialization, are not exclusive of it. For instance, the usage of an AR-enabled multiscanner can improve handling bulk consignments without any error, which has a greater possibility during manual handling. With the aggregation serialization in place, scanning the pallet alone makes the process even faster.

Additionally, a traceability suit during the process of VRS, coupled with a multiscanner can scan, capture and store the data in a highly secured central data repository that can be seen by any of the stakeholders as well as the government agencies for verification. This stage is interoperable too. The data stored from the serialization process is used while verifying the saleable returns that need re-deployment in the mainstream drug circulation.

Now, how does that impact the revenues? Multiscanners eliminate the use of additional manpower to handle the authentication of drug consignments. In fact, these AR-empowered multiscanners have a proven track record of completing close to 30,000 scans in merely 7 hours. Ne can imagine how convenient the serialization process becomes with more time to concentrate on the documentation process rather than on the tedious manual serialization that amounts to extra costs.

The centralized data inventory where the data is stored can be synced with any software, thanks to the API-first approach that third-party traceability service providers like TrackTraceRX have opted for. No matter the operational framework, the repository can easily communicate with any of the stakeholders in the supply chain enabling data transparency.

Serialization is the only way to secure the integrity of the drug supply chain. Investing in proper technologies and software not only improves the critical success factors that determine the efficiency of a serialization process but also ensure that stakeholders spend less and get a higher return on investment.