Pharmaceutical Product Serialization

This Blog will help to understand on how critical for any Pharmaceutical industry to follow the Product serialization

1. Why Product Serialization

In today’s world, with the increasing number of drug counterfeit, theft, diversion or false product returns are becoming challenging effort for any organization. This has been constant battle against increasingly sophisticated and organized counterfeiters. The human suffering with counterfeit drugs is unbearable; also it’s estimated around $75 billion the global pharmaceutical companies lose to counterfeit or stolen drugs.

With the growing threat, many countries have started to address vulnerabilities for this in supply chain system. This would require having comprehensive approach to implement product Serialization with track and trace capability.

2. Challenges

The very extent of counterfeiting is unknown but according to World Health Organization, the estimate is up to 15% of all medicines are counterfeit and there was a record rise of 92% in seizure of falsified products between 2005-2011. Alarmed by the proliferation of counterfeit medications, different countries trying to implement product serialization backed by overarching global initiative managed under WHO. These regulations aimed at protecting public health, intellectual property rights. The national security will require pharmaceutical, medical device and consumer packaged-goods manufacturers to track and trace products across the supply chain.

The entire set up is managed by International Medical Products Anti-Counterfeiting Taskforce (IMPACT) which developed principles and elements for national legislation against counterfeit medical products.

3. How do we achieve it

Product manufacturers while packaging, updating of lines and installation of serialization-capable coding equipment may appear to be a project much like any other. Installing serialization-ready equipment is slightly complex but coding technology used should be best suited for serialization. The transition from lot-level tracking to unit-level serialization and traceability creates an explosion of compliance data, which must be generated and managed along with a massive increase in transaction events, which must be managed at operational speeds. The data generated for serialization, master data and transactional information related to a uniquely serialized product that is captured and shared as a product is packaged, shipped and verified across the supply chain. This is in order of magnitude larger than the related information associated with a product under lot-level production and distribution.

4. Current strategies around the world

Many countries are making it mandatory to implement exclusive coding to their pharmaceutical products. The following picture shows the situation of those countries to implement serialization and some of them are country specific . As it is noticed many countries including Argentina, Brazil, China, EU, France, India, South Korea, Turkey and USA have completely/partially implemented serialization to maintain supply chain integrity and to ensure patient safety.

5. Players in market

It’s inevitable to have robust and comprehensive solution for any Pharmaceutical company to implement Serialization. Many IT solutions are in market which has precise, country specific solutions implemented to serve Pharmaceutical industry.

Some of the IT players who have solutions are:

1. SAP AII/OER with GTS or ATTP
2. Traceable Quality System (TQS) from OCS
3. Tracelink
4. Verify Brand’s pharma serialization
5. Ropack
6. Optel
7. Valuecentric
8. Systech’s UniSeries? suite
9. TQS – THE OPTIMAL MODULAR TRACK & TRACE
10. METTLER TOLEDO
11. CRB