Cork, Ireland. 9 June 2015
Serialization deadlines are looming for global pharmaceutical manufacturers. Within the next 10 years, strict new bar-coding regulations will be in place in major markets in an effort to curb the onslaught of counterfeit medicines entering the market. If pharmaceutical manufacturers don’t comply, they can’t do business. It’s as simple as that.
Implementing Serialization is a costly exercise and many companies are viewing it’s implementation in terms of expense instead of opportunity. Can Serialization bring benefits outside of regulatory compliance? This may seem a complex question to answer as pharmaceutical companies begin their serialization journey. It is difficult to look beyond the significant challenges that lie ahead in this undoubtedly complex project – initial funding and stakeholder engagement, vendor selection and delivery adherence, uncertainty in the regulatory environment and of course the numerous changes that will impact packaging, warehousing and supply chain processes. However despite lots of challenges, serialization can deliver valuable business benefits to the pharmaceutical manufacturer. The core objectives of a pharmaceutical organization’s serialization strategy are fundamentally to provide enhanced product security and thereby provide safe, unadulterated medicines to patients, whilst ensuring business continuity and safeguarding their right to continue to supply medicines that meet regulatory requirements.
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” of supplying counterfeit medicines is to the criminal gangs behind this practice. Serialization provides perhaps the most effective weapon the pharmaceutical industry has yet adopted to fight against counterfeiting and ultimately protect patient safety. Combined as part of an organization’s brand protection strategy, serialization, alongside existing safety features, not only protects the patient but also from a business perspective protects the organization’s brand. Publicity associated with any incidents of counterfeiting creates a significant threat to even the strongest brand.
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’s control. In the event that a product is in the market and has to be recalled, with a serialized system in place, the organization will be able to respond much more rapidly to this situation. Timeliness is key in dealing with such events in order to protect the patient, demonstrate control of the supply chain and the quality management system procedures to the regulators, and ultimately limit the damage to the organization’s reputation.
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 behavioral 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.
Contact us to discuss how we can assist you in reaching your local and global obligations and optimizing your serialization strategy.
About The Author
Yvonne Sargent is a highly experienced pharmaceutical and biotechnology professional with specialist knowledge of packaging and GMP systems. She has worked for leading global companies and delivered results in areas such as project management, packaging hall design, process development, packaging validation, operations management, lean six sigma, implementing 2D coding and serialization on packaging lines.