The world of pharmaceutical packaging is replete with confusing and disruptive market conditions. One of the most daunting challenges today involves assessing and addressing new global regulatory requirements and the shifting timelines for serialization. There are immediate, intermediate, and future regulations that are, literally and figuratively, all over the map—and the calendar. For instance, immediate requirements such as French CIP13 coding or those emerging from the Turkish Ministry of Health appear to be vastly disparate technologies with varying deadlines for compliance.
Other regulatory bodies in Europe, South America, and Asia are quickly following suit with their own requirements for pharmaceutical tracking and reimbursement initiatives. Amid the flurry of country-specific initiatives, the European Commission has proposed legislation to prevent counterfeit products from entering the legal supply chain, and the U.S. FDA has issued guidance for the creation of Standardized Numerical Identifier (SNI) legislation.
Pharmaceutical manufacturers need to meet current regulatory requirements and implement plans to prepare them for whatever the global regulatory tides bring. “Manufacturers facing this diverse regulatory environment are often tempted to default to tactical solutions that address short-term requirements. Manufacturers can instead adopt a comprehensive approach based on productized solutions that addresses regional needs today but also provides scalability for future needs,” according to Joe Ringwood, COO, Systech International.
Systech, a developer of Packaging Execution Systems (PES), has more than two decades of experience in vision inspection, line management, and serialization deployments for the pharmaceutical industry. The company currently has 150 serialization lines installed, in process, or under contract worldwide. As a result of its experience, Systech has identified a list of seven “Lessons Learned” to help companies plan for this disruptive environment. These lessons should be considered when planning a serialization initiative.
1. Serialization is a business strategy. While regulatory compliance is a major driver for serialization projects, leading pharmaceutical companies are unlocking additional value by taking a comprehensive approach. Successful manufacturers develop enterprisewide strategies encompassing packaging, information technology (IT), and other disciplines. These strategies address the organization’s view of serialization from the standpoint of patient safety, brand protection, and supply-chain operations. Industry leaders recognize that individual drivers, such as country-specific regulatory requirements, may drive local requirements and timing, but the overall adoption of serialization is strategic to the enterprise.
New regulatory requirements are often fluid and unpredictable in terms of enactment and enforcement. For example, some manufacturers viewed last year’s delay in California’s e-pedigree requirements as an opportunity to shelve serialization projects. However, many leading pharmaceutical packagers simply adjusted the focus of their deployments from North America and compliance to Europe and brand protection. Companies with a serialization business strategy have more control of their destiny and will likely be positioned to unlock potential future benefits.
2. Serialization must be a cross-functional endeavor.Serialization is not just a project for an individual functional organization or location. As mentioned earlier, serialization is disruptive and requires changes and planning in packaging, quality control, distribution, and IT, just to name a few. As discussed later in this article, serialization forces packaging technology and IT to communicate in a bidirectional manner for the first time. Quality control sampling, packaging rework, central packaging, and palletizing need to be reengineered. Furthermore, uniquely identifying packages and associating serial number information to shipments and orders creates value beyond regulatory drivers. Value opportunities may be identified with regard to product authentication to combat counterfeiting, understanding diversion and parallel trade, delivery confirmation, chargeback and returns processing, and supply-chain visibility and optimization. Leaving key players out of the serialization initiative can lead to avoidable challenges, problems, and missed opportunities. Addressing serialization with an enterprisewide cross-functional team during planning, deployment, and operation, along with a business strategy for serialization, can minimize investment and maximize value.
3. Serial number control in packaging is fundamental. Serialization is far more complicated than placing a number on a package. To ensure serial numbers can be used in distribution processes and by supply-chain partners, control of the serial numbers and serial number data must be maintained throughout packaging. This includes maintaining control of items going into bundles, cases, and pallets both on and off the packaging line. Use cases are needed throughout the packaging line from labeling or carton printing or encoding, bundling, case packing, and palletizing. Use cases must also address the dynamics of each automated and manual process. They need to consistently manage both normal and exception processing. From a line management point of view, real-time coordination of multiple high-speed processes, involving printers, cameras, readers, and other intelligence devices, is necessary to maintain control of serialization. Without absolute control of serial number integrity, packaging, serialization numbers, and associated data are useless.
4. There will be multiple requirements for each packaging operation. In order to get high utilization of expensive packaging assets, companies often package multiple products on a single packaging line. If a line packages product for multiple jurisdictions, it will need to be flexible enough to support multiple serialization and coding requirements. Furthermore, if the same product is distributed in multiple markets, the product may need multiple codes or serial numbers.
Even when a product has just one code, the automated system managing serialization must handle multiple numbers for each item in real-time. Why? Because the different formats for storing data, communicating data, or printing (bar code and human-readable text) or encoding (RFID) the data represent unique numbers for the same item. Here is an example: New serial numbers may be created in an IT system and communicated to the packaging serialization system in a format referred to as a Tag URI (universal unique identifier protocol commonly used in various Internet-related technologies). The serial number may need to be printed in as a two-dimensional bar code, which requires the data to be in a format specified by GS1 (standards body) often referred to as the AI(01) (product code) AI(21) (serial number) format. The same number also needs to be put in a text format as a human-readable backup to the bar code. When items are put in a case, the case serial number may require an additional bar code in a format referred to as SSCC-18, or an SSCC-96 format if an RFID tag is used. The integrity of these numbers and their association to physical products is absolutely critical to the success of serialization. As stated earlier, if the integrity is lost, the serial numbers and the associated data are useless.
5. Bidirectional communication between packaging and IT is a must. In order to meet regulatory and other drivers, serialized product data must be integrated with business data (such as orders or shipments). To get strategic value, serial numbers are typically controlled and maintained at an enterprise level in an IT system such as an EPCIS data repository. To successfully serialize products in packaging, data from the enterprise IT system must be communicated down to the packaging line, and information must flow from the packaging line back up to the IT system. Bidirectional communication does not typically exist between packaging and IT. Traditionally, packaging and IT environments are maintained separately with little interaction beyond manual input of summary data. Enabling this communication requires a new layer of automation control (see image above).
This new layer of control represents a gateway through which data must flow. The gateway ensures integrity of data in IT systems. It also makes sure throughput and availability of the packaging line are maintained. Without bidirectional communications, packagers will not be able to meet rapidly emerging serialization regulatory requirements or be able to realize additional value.
6. Existing processes and equipment will change. A typical packaging line, whether automated or semiautomated, is made up of specialized machines integrated into a single line. These machines (fillers, blister machines, cartoners, bundlers, case packers, palletizers, etc.) are set up to efficiently package identical products to exacting requirements. Serialization places the added dimension on the packaging process. This often means replacing or retrofitting existing packaging equipment. Use cases for the serialization system must consider the unique requirements of each packaging process. It is important to understand how serialization will work on the line before new equipment is purchased or modifications are made to existing equipment. Detailed requirements need to be communicated to machine builders and/or line integrators to minimize costly rework. When planning a serialization project, the amount of time to build new equipment and integrate it into a line or to modify existing equipment often becomes the critical path on the project. Long lead times should be taken into consideration when determining when a serialization project must begin to meet future regulatory requirements.
Packagers should also consider future serialization requirements when purchasing new equipment or building new lines. Let’s take, for example, the new coding requirements in France referred to as CIP13. While CIP13 is not a serialization requirement, it is a requirement to put a two-dimensional bar code on each item. This requires most packagers to add new print-and-verify capabilities to their lines. Installing solutions that can meet current requirements and are proven to address potential future serialization requirements is a wise move for most packagers. In other words, it is likely to be far less expensive to plan for serialization now than to retrofit existing equipment or lines in the future.
7. Leverage a productized solution. As depicted in the image on page 8, a solution for enabling serialization, in this case, Systech’s Serialized Product Tracking application or (SPT), includes many different components. The solution maintains control over serialization at the item, bundle, case, and pallet levels. The solution must support differing types of packages (blister, bottle, vial, etc.) and equipment on the packaging line. Serialization solutions need to support automated, semiautomated, and manual processes. Finally, they must manage serialization over multiple lines and as mentioned earlier, provide a gateway for bidirectional communications between the packaging environment and the IT environment.
While companies can try to build custom solutions, there are a number of downsides to this approach. Customized solutions tend to be limited in their scalability and adaptability. Custom solutions or a custom solution based on limited product software that only addresses some of the requirements are often not suitable for use across multiple lines with different packaging processes. When custom solutions are changed or modified, they typically require significantly more validation than solutions based on a productized offering. According to GAMP5 guidelines for a risk-based approach to compliant computerized systems, productized solutions based on configurable software typically represent less risk than customized solutions. As a result, configurable software requires less validation time and effort. Furthermore, a configurable productized solution can be deployed across many different packaging lines, with different machines and processes to meet multiple regulatory drivers and still provide a consistent interface to the IT environment. Along with a common user experience, using a productized solution minimizes the cost and effort to support the system and to train staff, thereby reducing the total cost of ownership.
“Making the right investments immediately in packaging operations can satisfy regulatory requirements and provide a platform for serialization that protects patients, brands, and supply chains from counterfeit threats,” concludes Ringwood of Systech.
Progressive manufacturers are moving beyond pilots and are deploying technology on multiple lines in many regions of the world. At the same time, these leaders are working with standards organizations, industry associations, and regulators to discuss, clarify, and refine standards and best practices based on their experiences.
Packagers recognize that additional learnings are required to execute strategies and to make serialization a useful tool in their supply chains. But they are not standing still.