An exclusive Q&A with American Health Packaging on implementing serialization, understanding the DSCSA regulations, and challenges for companies up and down the pharmaceutical supply chain.
“Serialization” is a word that is on everyone’s lips in the pharmaceutical industry. As of November 2017, manufacturers will be required to have serialized their products, with more deadlines coming in quick succession thereafter.
Many companies have expressed their concerns regarding the implementation of the Drug Supply Chain Security Act (DSCSA) regulations, as well as voiced a number of questions—many of which are as yet unanswered.
Chris Purdy, Manager of Engineering at American Health Packaging, participated in an exclusive Q&A with Pharmaceutical Processing on some of those key questions. His edited responses are below.
In your opinion, what is one of the biggest misunderstandings with regards to implementing the DSCSA?
Since a lot of companies are new to DSCSA, it is usually unclear what the requirements of DSCSA are. For example, some companies confuse the requirement of having aggregation completed by the serialization deadline. Aggregation is much further out in the milestones for DSCSA. However, a lot of companies decide to complete the aggregation phase earlier. There is a constant need for familiarization required with DSCSA and confirming that the correct system is put in place.
What are companies’ biggest concerns with implementing DSCSA regulations?
From a production standpoint, the biggest concern is implementing the required systems while still meeting current production demands. The process is time consuming, and companies need to thoroughly discuss the best way to proceed in order to provide a reliable system that meets the requirements while continuing normal production to meet demands. Identifying a reliable vendor and creating a partnership is critical.
The big implementation deadline for manufacturers is November 27, 2017 when they have to have serialized their products. What are some of the practices that are currently in place for manufacturers and how will the DSCSA affect these processes?
Current procedures are in place for companies to produce product and release to the market. Additional steps will be added as part of DSCSA. The system will look different in regard to additional steps/layers throughout the process to create a more robust system.
What do you foresee as the greatest challenge for manufacturers, repackagers, distributors, and dispensers to meet the various serialization deadlines?
The biggest challenge is vendor availability. There are limited vendors that can implement a full system in the current timeframe that is present—depending on how long they waiting to start the process. However, more and more are gaining capabilities each year. A lot of the big serialization companies are turning away business due to their current demand. Companies have waited to get the discussion started and are finding it more difficult to proceed with certain vendors that assist with implementing serialization.
What are some of the steps that manufacturers and repackagers should take to prepare their operations for serialization?
Capital funding availability is critical as well as creating clear and concise specifications for what is required of the system/process. Partnering with a reliable vendor that knows DSCSA is one again critical.
What do you foresee as one of the biggest challenges for all segments of the industry to have implemented serialization? Unit-level traceability?
Keeping up with changes to requirements is a challenge. Understanding what is required and partnering with a reliable vendor to verify that these requirements are met. Changes to processes, training, and understanding why it is required is necessary to implement a full system.
How can companies best accommodate all of the necessary serialization information on the same package?
Certain changes to the current packages may be required. Companies are making changes to labeling to give themselves more space to print the human readable data and 2D barcode. Limited space makes it necessary for these changes.
Would you say there is a different level of difficulty for different companies along the supply chain to be in compliance (manufacturers, repackagers, distributers, dispensers, etc.)?
Each level has its own challenges. Manufacturers and repackagers need to install the necessary systems and equipment to meet regulations while minimizing downtime and continuing production to meet demand. Distributers and dispensers require changes to receive serialized product especially since they will be receiving from various manufacturers. So a flexible system is needed.
How do you foresee the DSCSA impacting the pharmaceutical counterfeit market?
Current counterfeit techniques will no longer be successful. It will hinder counterfeiters and their current capabilities preventing counterfeit product to reach the market.
In your opinion, what will be the greatest benefit from the DSCSA once it is fully implemented in 2023?
The greatest benefit is having a secure supply chain that will track the history of a serialized unit—which is critical to confirming that a safe product is delivered to the customer.