at various points throughout the supply chain on a
central server or on the product itself; facilitating the
discovery of where counterfeit products have entered
the supply chain – end-to-end. Additionally, serialization of each unit provides companies visibility into
their supply chain down to the unit level of every
event, as well as providing visibility for optimal inventory forecasting. The visibility translates into chain of
custody and ultimately the accountability required to
safeguard patient health and safety, as well as ensuring access to medicine via inventory management.
Track and trace goes below the surface of medicines alone, and safeguards the active and inactive/bulk
ingredients. Hence, supporting the adage it is only as good
as what goes into it. Track and trace also provides for full
traceability of products globally as well as regionally.
The prevalence of counterfeits continue to grow. Counterfeit
drugs effect safety, public health, drug supply of approved
drugs and drugs needed for development, and pose a serious
threat to manufacturers who seek to protect their brands and
continue innovating. Counterfeiting erodes the trust we have
in our healthcare providers, regulators and the legitimacy of
research, scientific development and medical treatment. ■
regional and local regulations vary. To address this, stakeholders seek to harmonize coding with GS1 standards, as well as
unique identifiers such as GTINs. Manufacturers are also implementing serialization systems to implement product authentication and through track and trace create product pedigree.
Requirements for serialization and subsequent accountability and chain of custody has spanned across the globe
and has been fueled by countries demanding serialization
from their import/export trading partners. For example, in
order to continue to comply with regulatory mandates in
European and future US markets, India and China have begun implementing serialization and chain of custody requirements into manufacturing processes and practices.
ELIMINATING RISKS OF COUNTERFEITS: TRACK
AND TRACE TECHNOLOGY
Given the complex and fragmented nature of global pharmaceutical production and consumption, track and trace
technology, solutions and services are fundamental to safeguarding patient safety and protect product integrity.
Track and trace technology is a simple and effective way to
leverage basic serialization and item level identifiers and protect
patients and consumers against counterfeiting and substandard
medicines. Its advantage is that it enables the serial number
also known as a Unique Identifier Number (UIN) to be recorded
© 2013 Capsugel Belgium NV All rights reserved.
Vcaps® Plus hypromellose capsules for pharmaceutical products
Secondary gelling agents and ionic gel promoters – used by other
HPMC capsules – may slow down release of active ingredients.
Capsugel’s Vcaps® Plus HPMC capsules are made through a proprietary
manufacturing process that eliminates the need for gelling systems.
They disintegrate and release their contents independent of pH and ionic
strength of the test media. Download our free whitepaper to discover
how Vcaps® Plus capsules can optimize performance, improve product
stability, and reduce drug development times.
Achieving new standards in performance takes
years of innovative R&D. This is the result.
Track and trace
globally as well