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Serialization - the benefits and the challenges

The pharmaceutical industry is increasingly falling victim to counterfeit medicines and theft throughout the supply chain, with the World Health Organization (WHO) estimating counterfeit levels at 1% of supplies in developed countries (millions of prescriptions) and 30-40% in developing countries. Through comprehensive systems, tracking and tracing are enabled along the supply chain.

The prevention of this through identification is just one of the benefits seen from serialization. Serialization refers to the allocation and situation of unique markings on packaging. These can be two-dimensional such as a bar-code or a numerical code. The codes are stored on a database, which can be accessed by various parties along the supply chain, including pharmacists and law enforcement.

The benefits of serialization are expansive, through retrieving data and maintaining consumer safety.

 The benefited areas include:

1.       Regulatory and legislative

2.       Supply chain synergies and efficiency

3.       Brand protection

4.       Anti-counterfeiting supply chain

5.       Patient safety

Regulations have been put in place internationally, and although there are different formats for each country, each nation’s are built around the global requirements.

Implementation challenges:

Serialization is a complex process, and if not implemented properly, can be a very costly one.

Key challenges include:

·         The creation of suitably unique codes for individual products during production

·         High speed printing and verification

·         Cross-site coordination for serial generation for similar product lines

·         Optimum utilization of existing technology and machinery – Before serialization places an additional dimension to it, the packaging line must be revalidated as equipment is added or altered.

·         Change management – employees must be trained on the new equipment

·         Data storage risks– quality, accuracy, security and reliability. The packaging and IT systems must be fully integrated or the rapid regulatory deadlines will not be met.  

 

Join us on Day 1 for a panel discussion exploring how to overcome key operational challenges within serialization to optimize this complex process.

·         Exchanging serialization experiences to find ways to effectively capitalize on serialization’s advantages

·         Exploring the challenges with serialization process from various perspectives such as labeling, packaging and supply chain to manage the system as a whole

·         Managing the challenges of assembling bottles and packaging according to serial numbers to minimize cases of having to restart the process by developing more cooperation between P&L

·         Presenting innovations that can transform the serialization process such as vision systems and cameras to identify serial numbers and ensure if they are sealed correctly

Panel:

Michael Trocchia, Business Project Manager, CellChain Project, Novartis

Dave Mason, Global Serialization Lead, Sandoz

Nicole Quallis, Labeling Manager, Valeant Pharmaceuticals

Paul Nelson, Vice President, Supply Chain and Project Management, Amring Pharmaceuticals

View the full programme here