Serialization: A Road Map To Compliance

The implementation of serialization at a pharmaceutical manufacturing site is a worthy but seemingly monumental task. Although it has the potential to stop the global trade of illegal and counterfeit drugs, knowing the best way forward to successfully complete the conversion is often unclear. And, the disruption to normal business can be immense. It has been the buzz in the pharmaceutical community for the last five years, but with regulatory enforcement postponed, it has been easy for most pharmaceutical manufacturing companies to ignore, or at least de-prioritize.

One contract packaging company, the subject of the case study below, has taken the opposite approach. They decided to be proactive in the safeguarding process. They see it as more than just meeting regulatory requirements; they see it as an investment in the future. Serialization at their plant strengthens their brand’s focus on value, which they have carefully established over years. They want to continue to be the preferred contract packaging vendor of their current pharmaceutical clients, and they want to gain new business by being one step ahead of what those customers need. They see it as an important step in providing a seamless quality management system between their clients and the pharmaceutical packaging they do for them.

HISTORY

Although there is no global standard for consumer protection associated with prescription medications, most of the major countries involved in pharmaceutical production are drafting or have already implemented regulations to ensure drug traceability. Serialization results in the creation of a two-dimensional data matrix code which gives a unique serial number linked to the manufacturer’s product code, the expiration date, and the batch or lot number. When serialization is fully implemented, these unique identifiers give visibility and traceability within a supply chain from the production line to the pharmacy to the patient treatment venue. In addition to curbing the problems caused by the exploding counterfeit market, it can be used to effectively identify product that needs to be pulled out of circulation in the event of a recall and can be used to manage the inventory and distribution.

Regulators, like pharmaceutical manufacturers, recognize the need for tracking and tracing drugs but have a balanced appreciation for the impact on drug manufacturers and the mixed effect on consumers by enforcing laws requiring serialization too quickly. Shutting down the production of lifesaving drugs could drastically upset the health and well-being of our society. November 27, 2017 was the original date given under the Drug Supply Chain Security Act (DSCSA) by which U.S. pharmaceutical manufacturers were required to print a unique product identification code on all drug units for sale and homogenous cases distributed domestically. (Note: The FDA’s definition of a homogenous case is, “a sealed case containing only product that has a single National Drug Code number belonging to a single lot.”) On June 30, 2017, however, the FDA suspended prosecution and sanctioning for non-compliance with the statutory requirement until November 26, 2018 to allow the industry more time to get ready for the change and to prevent disruptions to the pharmaceutical supply chain.

CASE STUDY: CONTRACT PACKAGING COMPANY IMPLEMENTS SERIALIZATION

Once the contract packaging company decided to move ahead quickly with serialization, they created a project team to start the process. Even though the team consisted of less than 10 people, the opinions of all relevant stakeholders were gathered (e.g., operations, legal, distribution, labeling, regulatory, information systems, engineering, purchasing, customer service, and quality). Many of the internal conversations hinged on two critical points: 1) where we are today and 2) where we want to go in the future. They focused on the company’s internal needs within the manufacturing facility as well as the external needs of their pharmaceutical clients while making sure they were implementing the changes in a way that is compliant with government regulations.

• Internal Focus. All current business operations were reviewed to see if they were impacted by serialization. How could they minimize the impact on line efficiency, operations, and distribution — during the upgrade process and after serialization was in place — in order to keep their customer base happy? How should they roll out an aggregation strategy with a more comprehensive track-and-trace capability — gradually after the serialization is solidified or together with serialization? 
  
  Were their existing information systems robust and efficient enough to manage the added requirements of serialization?  They were quite certain the printer they used for their previous labeling would not be capable and fast enough to print 2D codes, but they wondered if they could port the data from new serialization equipment into their current IT backbone. They understood they needed to respond to the FDA within 24 hours of a request for verification of product identification coding: Would their IT system stand up to that task? How would they back up the data and recover from problems? How would they handle reworks, returns, and exceptions?

• Client Focus.  A review was needed to ensure their plan for serialization would work for past and future products they had manufactured. They noted potential problems and came up with a mitigation plan to overcome the difficulties. To verify they were on the right track and didn’t miss important details, they presented their high-level plan for serialization to their pharmaceutical partners and made changes where needed. They had open conversations about aggregation strategies with their clients to better understand if and when they plan to use aggregation data to more closely manage their inventory and distribution.

• Regulatory Focus. Several times through the planning process, they asked themselves if they had interpreted the regulatory requirements appropriately and to the satisfaction of their pharmaceutical clients. Several members of the project team attended industry conferences where serialization was a hot topic and concluded that they were proceeding in compliance with the expectations of the FDA. 

• Unified Step Forward. After they gathered answers to their questions, they had to create a budget and schedule for the project. They realized from the own projections and from the shared experiences of others that it would take a minimum of six months to implement the changes once plans were in place, giving a bit of room for unexpected complications.

Partnership with WIPOTEC-OCS

Even with all these details to sort out, the contract packaging company came up with an initial plan within four months and then started researching equipment vendors of serialization systems. They realized many of their lingering questions would be answered when talking to experienced vendors with technical knowledge of their systems and another view of the regulatory environment. They knew the best path forward would be to form a close relationship with a vendor that understood where they wanted to go and was able to help them achieve their goal.  To this end, they rated the vendors and invited representatives from their top two companies to their facility to meet and make presentations. WIPOTEC-OCS met and exceeded the contract packaging company’s expectations. 

The contract packaging company appreciated that WIPOTEC-OCS has a lot of experience in both serialization and aggregation. WIPOTEC-OCS has been installing serialization systems in Europe and in other global locations well before the regulatory environment around serialization heated up in the United States. WIPOTEC-OCS is a leading international company in the discipline and is very competitive in the marketplace. Most of all, the packaging company had good chemistry with WIPOTEC-OCS. The folks from WIPOTEC-OCS “speak the same language,” share common goals, are competent, open, and direct. 

The two companies met a few times and talked about the details of serialization upgrade. It soon was confirmed that the Traceable Quality System (TQS) from WIPOTEC-OCS was the ideal track-and-trace solution. The system provides maximum flexibility for their current serialization and weight verification requirements and their future aggregation needs. The plug and play design minimized downtime to the production line, and the compact footprint of the equipment allowed for easy integration without space restrictions. Since the bulk of the contract packaging company’s pharmaceutical manufacturing business involves drugs that are supplied in bottles, the initial serialization equipment was programmed to label individual bottles of drug product, plus the shipping cartons in which they are placed for storage in their warehouse and subsequent shipment. The flexible TQS platform allows for serialization of a wide range of bottle sizes, and if customers need other packaging formats, such as vials or blister packs, the same equipment can handle that.

The serialization equipment flawlessly passed factory acceptance testing (FAT) at the WIPOTEC-OCS facility. The site acceptance testing (SAT) of the equipment went smoothly as well, expedited by all the standardized formats used in the design of both the hardware and software platforms. The installation qualification and operational qualification (IQ/OQ) package included with the serialization unit was used to ensure proper performance. A traceability matrix defined all the requirements for the system, and passing scores obtained in test protocols confirmed the serialization upgrade was complete and ready to use.

Production managers and operators have found the system to be very easy to use. They appreciate that the TQS software uses open serialization communication standards, commonly called OPEN SCS, which interface with their enterprise system to offer efficient, convenient, and one-platform operation. They know they can move the first-installed serialization equipment to other production lines, but they realize the request from pharmaceutical companies for serialization will grow quickly and it is worth the investment to equip all of their drug manufacturing lines with similar units.

Conclusion

Detailed planning plus partnering with WIPOTEC-OCS has been a winning combination. The TQS track-and-trace equipment fit easily into the manufacturing line, and the serialization software was integrated into the existing IT system. The system offers the flexibility needed to label new items and take on a full aggregation strategy. In less than six months of implementation time, the first serialized pharmaceutical manufacturing line is open for business.