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ESP Outlines The Business Benefits of Serialization Beyond Regulatory Compliance
Serialization deadlines are looming for global pharmaceutical manufacturers. Within 10 years, strict new international regulations relating to packaging will be in place to curb the onslaught of counterfeit medicines entering the market.
At the very heart of the legislative and regulatory processes driving the need to serialize medicines lies patient safety, too many tragic incidents have occurred and are still occurring whereby patients have suffered adverse effects and even death due to unknowingly being exposed to counterfeit medicines. A visit to the WHO website provides shocking statistics and documents showing just how lucrative the “business”
Serialization has a significant impact on reducing the risk of product recalls from a labelling perspective which has traditionally been the biggest causal factor behind recalls. Generally serialization demands tighter in- process controls, documented risk mitigation strategies, enhanced technology, and tighter validation controls which all play their part is preventing recalls by increasing the likelihood of uncovering a labelling error whilst the product is still under the organization’
The positive impacts of serialization will be felt right through the entire pharmaceutical supply chain;
Product shrinkage/ losses will be reduced due to much better product visibility as the product moves through the supply chain,
Expiry date management will become much more efficient and stock write-offs can be minimized,
Sales forecasting accuracy will improve as more real time data flows into the supply chain,
Product diversion incidents whereby genuine product is fraudulently diverted to be sold in a different market than it was intended for will be greatly reduced with serialization,
Inventory management of both finished goods and consumables will be enhanced.
As a pharmaceutical manufacturer embraces the changes that serialization brings, they should seek process improvements, particularly at an equipment level on their packaging line – they need to fix things that need to be fixed, engage with operators and technicians, listen to their feedback, involve a wide team of people and communicate well and frequently. It is not enough to view serialization as an “add on” to their existing process – they need to challenge the status quo, encourage innovation, think about how things can be improved, become leaner and smarter.
Serialization provides a great many challenges to even the most dynamic organizations but it also provides opportunities, particularly in terms of colleague engagement and team working – from a cultural perspective this can lead to a behavioural and mind set change. Fundamentally serialization is a mandatory or soon to be mandatory requirement in most of the world’s biggest markets. The message is simple; to continue doing business, pharmaceutical manufacturers must comply. At the core of this is patient safety- arguably the biggest business benefit of all to be gained from serialization.
Enterprise System Partners (ESP) is a leading global consulting and project engineering company – supporting manufacturing IT solutions for the life science industry since 2003.
We offer specialist support and consulting services exclusively for manufacturing and supply chain operations in biotechnology, pharmaceutical and medical devices, with core focus on Manufacturing Execution Systems (MES) and serialization.
ESP has a unique blend of knowledge specialists from level 0 to level 4 and across the supply chain. This gives us a distinct advantage in the delivery of serialization solutions.
We have worked with many of the early adopters within the life science industry, developing and executing their serialization strategies so they are internationally compliant for the future.