A Guide To Pharmaceutical Serialization

By Gunter Schilpp

Considering the world is facing a persistent and increasing threat from counterfeit, misbranded, adulterated, or diverted prescription drugs, government leaders, politicians, and executives from major pharmaceutical providers are driving efforts to develop methods to reliably track and trace prescription drugs. Based on this growing threat, many countries have started to address vulnerabilities in the supply chain by enacting legislation which, among other things, requires a comprehensive system, most often referred to as serialization or in the United States as e-Pedigree (electronic pedigree). This growing movement toward utilizing serialization to track drugs will inevitably lead to the companies that are found to be receiving or sending unserialized drug shipments being fined, ordered to discontinue operations, or even being criminally investigated.

Most pharmaceutical companies have already started to focus on implementing serialization strategies and defining their needs on trusted partners with production line serialization solutions. All pharmaceutical companies will be affected by serialization regulations. It is not an option to wait and see; it’s imperative to be a leader in the industry.

The Basics Of Serialization
The basic idea behind serialization is very easy to understand but very difficult to implement in the manufacturing process. It requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain.

The vast majority of prescription drugs received by patients are safe. However, given the number of potential players in the supply chain and the differences in regulations and laws worldwide covering each of them, opportunities do exist for dangerous counterfeit and adulterated drugs to be introduced into supply.

In an effort to combat this risk of counterfeit and adulterated drugs, national regulators have pursued the need for serialization. A complete serialization program represents the complete history of a given product’s chain of custody from the manufacturer to the point of dispensing. Much of the early work around implementing solutions has focused on support of serialization using electronic solutions, both in terms of applications for managing serialization data, printing of human-readable markings, and sensory technologies for verifying these markings. While there are many advantages in early implementation of a serialization program, there is still much confusion as to how laws and regulations will evolve in the future.

Pharmaceutical manufacturers are investing in ways to uniquely serialize each unit and to register the parent-child relationships of units into larger containers, cases, or cartons and even up to pallets.

The information required in a serialization program is strongly dependant on the many different laws and standards. Typical information could include some or all of the following:

• The complete supply chain ownership information from the manufacturer all the way down to the pharmacy from which the prescription drug was handed out to the patient
• Detailed information for each person who certified delivery and receipt of the prescription drug including company, name, and address
• The name of the prescription drug, its quantity, its dosage form and strength
• The date of each transaction in its distribution
•  The sales invoice number(s) for each transaction
•  The number of containers for each transaction
•  The expiration dates and the lot/batch number(s)
•  Complete shipping information
•  A certification that the information is true and accurate

Minimum Serialization Implementation Requirements
While the long-term requirements around serialization are still uncertain, the ability to track a specific drug product through the supply chain and trace its exact journey will help secure the integrity of the drug supply by providing accurate documentation. The minimum requirements for a complete serialization program also vary from country to country and could include one or all of the following points:

•  Authentication and certification of each owner of a prescription drug from the current owner back to the original manufacturer
•  Validation that serialization data matches the physical product received
•  The means to check that all prescription drugs in stock have been serialized
•  Association of serialization information when dispatching products
•  Confirmation that products have complete and accurate documentation

Only an automated electronic solution will be able to meet these requirements. These solutions need to be designed, implemented, and operated to address the unique challenges they present. Such an automated electronic solution will lead to very large amounts of data, which will need to be shared with all trading partners. Some of these challenges include:

• Data Volumes: Serialization data will require a significant increase in the data volumes shared between trading partners.
•  Information Storage: Each player in the supply chain will need to maintain complete and accurate records of all items back to the manufacturer for multiple years.
•  Reliability: Serialization information must be available before a product can be dispatched.
•  Certification: Each person in the supply chain must be able to authenticate the chain of custody back to the manufacturer, maintain a record of this authentication, and certify the shipments have complete and accurate documentation.

No matter how and when serialization laws are implemented, all pharmaceutical manufacturers, distributors, and retailers must be ready to comply and be ready to address these technological challenges.

Complexity
There are several factors that influence the total complexity, risk, and cost of implementing and managing serialization solutions, including regulatory uncertainty, technological evolution, and infrastructure requirements. Driving much of the complexity around creating and managing serialization programs is the complexity of the pharmaceutical supply chain itself. Prescription drugs are distributed to every corner of the world. Drugs are produced, distributed, repacked, and sold by hundreds of thousands of organizations. This complexity creates many questions about how best to address serialization and how it will affect the supply chain and distribution channels.

Regulatory Uncertainty: There are many unanswered questions regarding serialization requirements even though the first significant laws came into effect in 2006:

•  Will existing national law need to be changed?
•  Will serialization be required from all countries?
• l Will there be a global standard?

Requirements in 18 months may be significantly different from what they are today. For example, the industry has already started to mass serialize drugs, and there are already standards and concepts being implemented in Europe and the world today.

It is not foreseeable if one system will be adopted as the global standard or if each continent will have its own standard. Existing laws will need to be changed as the regulatory bodies get experience with their laws to close loopholes. These laws will require changes to the underlying software and production equipment supporting serialization compliance. The cost of upgrading is a major concern in determining the total cost of production. Initial implementation and investment cost are also an issue. Will the equipment you buy today be able to comply with future serialization requirements and laws?

Choosing The Right Production Line Equipment Supplier
Given regulatory uncertainty, technological evolution, and infrastructure requirements, early adopters are establishing long-term relationships with strong partners who can help manage costs and minimize risks.

Some of the points which need consideration include:

• How informed is the partner with current regulatory requirements? This is important to ensure required functionality is available in the solution and also ensures that the partner will be a valuable contributor in longer-term strategic initiatives.
• Is the partner able to supply solutions using tried and trusted components and technologies already in use in your production line? This will save considerable integration costs and time.
•  Has the partner demonstrated the performance needed to meet the requirements?
• Does the partner have the financial stability and resources to meet near-term requirements and to deliver an economical service in the long term?
• Does the partner have global service and support strategically located for rapid response when needed on-site?
• Does the partner’s solution have the flexibility to integrate your current software and hardware requirements, including the ability to incorporate new features as technology and requirements evolve?

There are many critical factors that need to be addressed when choosing a serialization equipment supplier. Take a quick look at the three types of specialized equipment components essential for the physical serialization of pharmaceutical products.

Vision Equipment: The vision system receives the serialization data from the central database, sends the information to the printer, and examines the package marking to verify the marking is legible and correct before signaling back to the central database that the serial number has been allotted.

Printing Equipment: Use an inkjet printer or laser marker that prints directly onto the packaging, or use a labeler.

Checkweighing Equipment: This equipment ensures the contents of each package, as marked and verified, are present and that each package is complete. It is ideal to place serialization marking and verifying equipment on or directly before the checkweigher to maximize critical quality control points.

The software solution for management of internal and external databases is also a crucial consideration for all installations and must be flexible enough for adaptation to future requirements.

Postserialization
Investing now in a serialization-related infrastructure goes beyond compliance. It should be considered as an overall strategy of supply chain safety, security, and efficiency. While safety is a major factor, the cost of delivering pharmaceuticals is also of great concern. It is essential for all pharmaceutical supply chains to supply the right quantity of the right product at the right place at the right time — as the cost and consequences of not achieving this goal are extremely high. Chain of custody technology can be a key factor in improving customer service and satisfaction.

About The Author
Gunter Schilpp is a marketing manager at METTLER TOLEDO and is responsible for global marketing activities of checkweighing applications and solutions. He has more than 14 years experience in the packaging industry and holds a degree in Industrial Engineering and Management and an MBA focusing on International Management.