completing additional DSCSA requirements prior to their actual deadline. For example, product tracing by package level is a
DSCSA provision required by 2023. However, several companies
provide solutions today that satisfy the current understanding of
SOLUTIONS BY DELIVERY METHOD
A selective history of track and trace begins with consumer
products. Many of us remember the rainbow-hued stickers on
the packaging of computer software office productivity CDs. A
license number appeared on each sticker that activated the software when the characters were entered into the computer. The
automobile parts industry and other industries developed their
own systems. The international pharmaceutical industry adopted
track and trace systems several years before the U.S. Turkey, for
example, manages a national track and trace system that already
functions in a similar fashion to the program envisioned by the
DSCSA to be operational in the U.S. by the year 2023.
When the DSCSA became law, the pharmaceutical industry
in the U.S. experienced a rush to market from several solutions
providers. After witnessing some industry consolidation, there
remain many approaches to achieve serialization compliance for
Contract packaging operations must select solutions from
among the many companies and options based on the delivery
method handled by their equipment. The hardware required for
compliance on an oral solid-dose packaging line may be a different solution on a liquid-dose line. Different providers may specialize in specific delivery methods. Decision-makers at contract
packagers must analyze whether to rely on a single vendor or
diversify potential risk across multiple suppliers.
AN IMPLEMENTATION EXPERIENCE
WDPrx – Woodfield Pharmaceutical is a CMO specializing in
non-sterile liquid and semi-solid manufacturing. Packaging and
labeling capabilities include semi-solid, liquid, gels, suspensions
and solid-dose delivery methods. After a thorough evaluation
process, the company selected Optel Vision, headquartered in
Quebec, Canada to upgrade all packaging lines with DSCSA
compliant optical and labeling systems.
Optel Vision offered a range of products for WDPrx that accounted for variations in packaging volume and level of automation required for each active line. Linear barcode scanners are
being upgraded to 2D scanners. Labeling equipment is also being
replaced or enhanced on all lines to meet DSCSA compliance.
The level of automation integrated into each line is dependent
upon packaging volume. Optel Vision is fully automating certain
lines and is installing semi-automated solutions on other lines to
better match variations in production quantities.
Systems to integrate equipment and information technol-
ogy assets with product tracing, verification and end-to-end
serialization, also known as Level IV enterprise compliance, are
being provided by TraceLink, creator of the TraceLink Life Sci-
ences Cloud, the world’s largest pharmaceutical track and trace
network. The TraceLink Life Sciences Cloud supports serializa-
tion programs by catching serial number generation requests
from packaging line systems, generating DSCSA-compliant se-
rial numbers and related data based on pre-defined profiles for
specific product types and packaging hierarchies. Resultant seri-
alization data, aggregation information, commissioning events,
shipment events and other operational events are exchanged
between the TraceLink system and various packaging line and
distribution systems using standard GS1 EPCIS and other data
exchange methods depending on the data exchanged and the ca-
pabilities of the target systems.
Lot-level compliance data is exchanged today and archived in
the Life Sciences Cloud to document products as they are bought
and sold across the pharmaceutical supply chain. As serialized
products start to become available across the supply chain to
meet the 2017-2020 DSCSA regulatory deadlines, many companies are now starting to gear up for serialization data exchange
between upstream and downstream parties on the Life Sciences
Cloud platform to support efficient business operations, when
required for verification of saleable returns or suspect products,
or for further review or examination to help minimize product
diversion and counterfeiting.
SOLUTIONS FOR SEVERAL LEVELS OF DSCSA READINESS
Pursuing a program to implement comprehensive DSCSA serialization capabilities prior to FDA deadlines provides CPOs
with additional new business opportunities. The CPO that is the
furthest along with the most comprehensive DSCSA-compliant
solutions is in the best position to address the specific needs of
all participants at both ends of the pharmaceutical supply chain.
Packaging and labeling operations fulfill a key role within the
pharmaceutical supply chain. Contract packagers manage relationships with multiple parties along the supply chain including
pharmaceutical manufacturers, contract manufacturing organizations, third party logistics providers, distributors, wholesalers
It is likely that all parties are at different stages of DSCSA
compliance. For example, some manufacturers may have equipment installed however it may not be validated. A CMO might
have Level IV integration completed however installation of 2D
readers on their equipment may be delayed. Smaller suppliers
may not have any serialization plan in place.
There is a strong possibility that orders fulfilled by the CPO
will be shipped to wholesalers, distributors and healthcare providers that also are in various states of readiness to accept serialized product.
In these cases and in other similar scenarios, the serialization-ready CPO is able to respond to clients with customized solutions
and is positioned to attract additional business based on the flexibility of their capabilities.
A WORD OF WARNING
Two strategies predominate in the industry regarding serialization. One position advocates completing the minimum requirements of the law prior to the deadline and takes a“wait and see”
attitude, not committing additional resources until further clarification and guidance is issued by the FDA about future implementation. This argument, expressed by some large pharmaceutical manufacturers, holds that major wholesalers will not halt the
flow of pharmaceutical drug products after the deadline if com-