Key challenges and lessons learned
By Bill Lydon
During the 2017 ISA Food and Pharmaceuticals Industries Division (FPID) Symposium, I attended an informative presentation by John Woodburn on the implementation of serialization and lessons learned. Woodburn's career at Sanofi spans more than 10 years and includes roles as deputy director of engineering, automation platform, and as North American regional project leader for serialization. Before working at Sanofi, he spent eight years as an engineering manager for Johnson & Johnson and two years as a project manager for Pfizer.
Woodburn gave an overview of a major serialization program that includes 58 sites in 21 countries, installed on more than 350 packaging and distribution lines. This centrally managed program uses one common solution architecture for all sites, and uses globally standardized equipment at the line level. The global program started in 2010 as a pilot and was implemented in Turkey in 2011 (28 pack lines and a terminal in the distribution center). It was formed by the industrial affairs organization to incorporate representatives from all stakeholder groups, including quality, supply chain, information technology (IT), manufacturing, and engineering.
The program management methodology in place includes rollover scheduling of the implementation, estimation for each year based on regulation compliance, and key milestones tied to regulation. The organization identified risks for market readiness, including late site capital request submissions and approvals, on-time delivery of corporate and site-based solutions, and vendor capacity to deliver equipment and software. The serialization program is regulatory and driven by country: Korea (2015), Saudi Arabia (2017), U.S. (2017), and Europe (2019). Aggregation is required in Turkey, China, Argentina, India (tbc), and U.S. (2023).
As government agencies and the pharmaceutical and life sciences industries take measures to reduce drug counterfeiting, diversify products, and increase patient safety, drug manufacturers are faced with the challenge of implementing serialization and tracking systems. Globally, plans are underway to require track-and-trace documentation. Manufacturers will have to provide an electronic record that contains information regarding each transaction. This requirement will result in a change of ownership from a manufacturer's sale of a given dangerous drug, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until the final sale to a pharmacy or individual furnishing, administering, or dispensing the drug. Serialization, however, is not yet harmonized worldwide due to varying standards. This presents a challenge for manufacturers. In the U.S., for example, the Drug Quality and Security Act (DQSA) was enacted by Congress in 2013, but the Food and Drug Administration continues to delay enforcement, with the latest deadline moved to 27 November 2018 and implementation of all requirements currently targeted for 2023.
GS1 Standards, which are already used in 25 different global industry sectors, appear to offer the best opportunity to achieve a single global standard. GS1 is an international not-for-profit association with members in more than 100 countries. GS1 is dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world. These standards define how products, services, and businesses are identified for electronic commerce by using alpha numeric characters formatted in a specific fashion. These specifically formatted identifiers are commonly represented on products as two-dimensional data matrix bar codes or radio frequency identification tags used by automatic identification systems to avoid data transfer errors. All the information collected in production and on packaging lines needs to be stored in the enterprise business system. In the future interoperable world of distribution, this information can be sent to those pharmacies where product is delivered to the consumer.
Standardized global approach
The program has global sponsors throughout the organization, including manufacturing, supply chain, information system, and quality. There are many advantages to a standardized global approach:
- Many resources from multiple sites are available to tackle a common objective.
- Knowledge and testing is centralized.
- Tests can be executed once and leveraged across many lines (370).
- Capital costs are reduced, and the organization has better cost control (through buying power).
- Vendor documentation is reduced.
- Continuous improvement lessons from one site can be implemented at the next.
Extra time is required for global alignment and coordination.
Serialization best practices
At item level
- At print and inspect, print on the package flap. Check the data matrix (two-dimensional bar code) grade equivalent and serial number uniqueness (duplicate check).
- If checking length, weight, and orientation, do the print check afterward to minimize manual decommissioning requirements and reduce the effect on overall equipment effectiveness (OEE) because of rejecting coded product.
- Quality control sampling: Sampling status, either manual or auto, this status must be locked.
- Shared packs: One unique identification/data matrix (DM) (national codes inside). If this is not possible, reduce or avoid shared packs.
Printer (to achieve a grading result of A)
- May require ink-to-paper substrate optimization.
- Print carton at the most stable location or idea surface.
- Optimum resolution identified as 240 dpi.
- Human readable text is 2 mm, with OCR-A or B font (print font recognizable by computers and humans).
- Have cartridge cleaning procedure in place.
Serial number generation
Data matrix location
- Standard: Print on the flap; preprint as much as possible, including the GS1 application identifiers (global standards for business communication), recognizing there will be some exceptions.
- Artwork and label position standardization should accommodate multiple countries.
RISK: Dual sourcing
- Standard: For item-level printing, the camera should be as far as possible from the print head to ensure ink is dry and to minimize the reflection of the modules in the area of the wet data matrix.
- Functions: All printed text must be optical character verification (OCV) checked, duplicate checked on the printed serial number, and grade equivalence checked.
- Aggregate the bundle only if required by law.
- Change the bundle wrapping to uncover the DM for ease of scanning.
- If pack codes are not readable downstream of bundling, the bundle must be labeled for aggregation (no virtual aggregation is permitted).
- Apply the label on the case in the case packer machine.
- Identify the case with a unique ID, where the unique ID equals the serial shipping container code (SSCC), unless there is another market requirement or law.
Solution: "core model"
- Apply SSCC pallet label immediately upon closing the pallet. Incomplete case/pallet:
- Palletizer: Case ID on label > check label > aggregate case to pallet
- Pallet should be able to move to the warehouse before the end of the batch.
Logistic unit labels: Harmonize to one global standard for all sites (bundle, case, and pallet).
- Other special considerations
- Serialization will have an effect (tamper evidence implementation, additional or new space for data matrix). As most artwork will have to be modified, develop artwork templates.
- Designations for cost, material scrap, engineering, installation, tests, quality validation
- Some countries request a specific national product code. This means that several data matrix codes have to be printed on the pack, which causes technical complexity and confusion at dispensing.
- Most shared packs will not be possible anymore. Only shared artwork can be used, but with late DM marking (late differentiation) or specific stock-keeping units (with batch size reduction).
Global IT standard
Zero defect acceptance criteria
If there is a zero-defect acceptance criteria for knowing which serial numbers are shipped, all lines will need aggregation.
There is great value in having a standardized global approach when deploying serialization. Extra time is required for global alignment and coordination, but advantages include:
- Many resources from multiple sites to tackle a common objective
- Centralized knowledge and testing
- Tests can be executed once and leveraged across many lines
- Reduced capital cost and better cost control (through buying power)
- Reduced vendor documentation
- Continuous improvement lessons from one site can be implemented on the next