Due to the importance of eliminating drug counterfeiting,
many countries have already adopted regulations requiring the
enactment of serialization. By 2019, the majority of the global
drug supply will essentially fall under some form of serialization
requirement. Countries that have already implemented this program include Turkey, India, Argentina, South Korea, and Saudi
Arabia. China started the implementation of serialization by the
end of 2015. However, they have placed a hold on their phased
implementation of serialization regulation and the industry is still
waiting for final guidance.
In the U.S., full implementation of serialization was originally
required by November 2017 and all products sold into the country had to be serialized by this date. This ruling represents one of
the most important rollouts of serialization regulations. However,
newly released guidelines offer a one-year reprieve for manufacturers, which have not integrated product identifier requirements
by the original deadline. This reprieve is also extended to trading
partners who may wish to purchase products without a product
identifier prior to November 2018. The one-year grace period is
due to the potential disruption to supply chains and the concern
that pharmaceutical companies and manufacturers are unprepared to meet the original deadline.
For manufacturers of pharmaceutical products there are several steps that must be followed and adhered to ensure compliance with the ruling. These steps include: the application of a
Global Trade Item Number (GTIN) including the national drug
code (NDC), a serial number, batch number, and an expiration
date. Cases in which the product is contained must be printed
with a linear barcode or 2D Data Matrix. Additionally, any requests from federal/state government organizations to verify serial numbers must be answered within 24-hours, and any data
must be stored/archived for six years.
The European Union has also enacted a compliance deadline
for EU member states—excluding the European Economic Area
(EEA), and Switzerland—beginning February 2019. Belgium,
Italy and Greece have an additional six years to comply. The requirements differ somewhat from the U.S., but also include serialization of the drug product at the smallest saleable unit. This includes the application of a unique product identification number
(e.g. GTIN/NTIN/PPN), batch/lot number, expiration date, serial
number, and if applicable, the national reimbursement number.
As in the U.S., a Code Format 2D Data Matrix is required. These
requirements are valid for all prescription drug products and certain over the counter (OTC) product drugs, which might be at
risk of falsification (blacklist products). While requirements from
the EU and the U.S. may differ on their approach to serialization,
legislators and authorities of various countries are united towards
one goal: achieving unique identification and clear verification of
the authenticity of products.
As with any new system or regulations, there are usually
CHOOSING A CDMO: WHAT TO LOOK FOR
impediments to adoption and implementation. With serializa-
tion, these include a tight schedule from the authorities that
require the regulations. Additionally, pharmaceutical and bio-
technology companies, as well as their manufacturers must al-
ways remain well informed about the current information as it
pertains to timeliness, different country requirements and any
changes that may arise. Contract development manufacturing
organizations (CDMOs) with a packaging service have to be
well prepared to result in a shortened timeframe for serializa-
tion projects. As such, the main challenges for manufacturers
in managing such a project can vary, particularly if the drug
product is supplied to several markets. A partner in the form
of a CDMO that can offer flexible serialization solutions allow-
ing for a rapid and efficient response to these variations may
be one option for helping a pharma company achieve success
in enacting serialization. But how does a company go about
finding the right partner to help with serialization, and what
attributes should they possess?
The choice of the right partner to assist with serialization is crucial in ensuring that it is properly enacted. Because serialization
requires a high-level of investment, it is essential that the CDMO
be adequately invested in programs, technology and expertise.
This is vital for the safety of the patient and the integrity of the
product. Also important is the existence of a pipeline for investment in future-oriented techniques and approaches.
The CDMO should be able to demonstrate a long history of
supporting customer and regulatory serialization demands. For
example, having already implemented an IT solution to support serialization, lines to print and encode serialization data
on packages, as well as the ability to manufacture products
that are serialized according to the latest regulatory guidelines.
Because implementation of a serialization service is a comprehensive project, a well-defined strategy and, preferably, one
that begins with a concept study to start the project is essential. This means that the CDMO should have an established and
solid cross-functional project team consisting of all the necessary departments including IT, engineering, production, supply
chain, quality, regulatory affairs and project management. Each
member of the team must have a strong working knowledge
of serialization and be kept abreast of any new regulatory requirements. Due to the vital importance of serialization, some
CDMOs have actually created the position of a Serialization
Process Manager. This function is responsible for ensuring that
all future requirements arising from different relevant markets
and customers will be implemented successfully.
Drug counterfeiting cannot, and should not continue to hold
the industry and the patients it serves as hostages. There are measures and steps that are currently being taken that are expected
to help battle this growing problem. Time will tell how effective
they will be. However, because existing programs like serialization can be costly, companies need to have the right resources
and support to ensure they are undertaken correctly. That is why
the choice of the right partner is vital. CP
DANIELA GEIGER holds a MBA in International Business Development from the ESB Business School Reutlingen, Germany.
She started her career path in the pharmaceutical industry in
2003 contributing to different areas of the business in Latin
America and Europe. Daniela joined Vetter in 2011. Currently
she works as a product and service manager, responsible for the secondary
packaging, serialization and sterile water for injection services.