PHARMACEUTICAL PROCESSING | JULY/AUGUST 2015 19 n
n PHARMPRO.COM n VA LID ATI ON
• Loss of revenue and market valuation.
• Brand and reputation damage.
The way quality control for validation is handled today
is typically through the manual sampling of raw materials.
However, most QC departments simply don’t have adequate
manpower to do this. Moreover, even if they did, it doesn’t
necessarily provide enough data to identify the actual
source issue or the specific goods impacted. This leads to
large recalls as only the batch can be identified, which can
potentially be millions of units.
WHAT NEEDS TO BE DONE
The supply chain needs to be secured from end to end.
Serialization has gone a long way to provide a form of identification for packaged items; typically at a batch level, enabling
manufactures to issue recalls on a wide scale. Combined with
track-and-trace technologies, the post-production supply
chain can potentially be secured when all partners in the process leverage a common automated system.
Unfortunately, when it comes to raw materials, serialization is not currently applied, nor is it legislated. However,
due to the issues previously discussed, it’s no doubt just a
matter of time. If you look to non-pharma industries such as
consumer electronics, most major brands have implemented
process, procedures and systems to secure their supply
chains to such an extent that it has become commonplace
for them to be able to issue recalls against individual products for specific faulty components.
Pharma and life sciences can learn from the consumer
product companies and reap critical benefits such as:
1. Ensuring consistent quality.
2. Reducing costs associated with recalls.
3. Continuously building brand trust.
4. Controlling counterfeiting.
5. Real-time authentication.
6. Developing consumer engagement channels (consumer/
Take a page out of the anti-counterfeiting book and combine it with serialization and track-and-trace to create the
ultimate secured supply chain.
1. Serialize the product and packaging lines (required for
2. Implement track-and-trace, extending it upstream to
shipping and distribution utilizing Internet-enabled
3. Implement track-and-trace technologies with raw
4. Integrate with QMS to support validation.
5. Deploy anti-counterfeiting and authentication solutions.
From the creation and packaging of raw materials,
through shipping and into production and upwards through
the supply chain, it now becomes possible to pinpoint a specific product at any point in its lifecycle, providing not only
supply chain security, but also business intelligence and
By building an ecosystem of suppliers, CMOs and CPOs
that leverage these technologies to build a secured supply
chain, manufacturers make validation simpler and quicker;
while at the same time increase their flexibility.
This level of visibility allows manufactures to know, in
real time, where the core ingredients originated and where
those ingredients are, by product, location, stock levels, etc.
This gives them a competitive advantage in controlling and
reporting on supply chain diversion, infiltration and gray
Taking it one step further, this technology can enable consumer engagement by encouraging consumers to ‘scan’ their
medication when they take it, providing a feedback loop to
deliver drug information on interactions, etc. and enable
automatic re-ordering. Most importantly, it can quickly and
efficiently notify end-users of a recall! The possibilities are
endless and a game changer for the pharma industry as a