Are There Business Benefits To Serialization Beyond Compliance?

By Yvonne Sargent, Packaging & Serialization Consultant, ESP

This may seem a complex question to answer as you begin your 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 your packaging, warehousing, and supply chain processes. However, despite lots of challenges, serialization can deliver valuable business benefits to your organization. The core objectives of your organization’s serialization strategy are fundamentally to provide enhanced product security and safe, unadulterated medicines to patients, whilst ensuring business continuity and safeguarding your right to continue to supply medicines that meet regulatory requirements.

Patient Safety

At the very heart of the legislative and regulatory processes driving the need to serialize medicines lies patient safety. A visit to the WHO website provides shocking statistics and documents on just how lucrative the “business” of supplying counter-fit medicines is to the criminal gangs behind this practice. Serialization provides perhaps the most effective weapon the pharmaceutical industry has yet adopted to fight counterfeiting and ultimately protect patient safety. Combined as part of your brand protection strategy, serialization, alongside your existing safety features, not only protects the patient but also protects your brand. Publicity associated with any incidents of counterfeiting creates a significant threat to even the strongest brand.

Reducing Recalls

Serialization has a significant impact on reducing the risk of product recalls from a labelling perspective — traditionally 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 while the product is still under your control. In the event that a product is in the market and has to be recalled, with a serialized system in place, your 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 your quality management system procedures to the regulators, and ultimately to limit the damage to the organizations reputation.

Positive Impacts

The positive impacts of serialization will be felt right through your entire supply chain:

• Product shrinkages/ 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 your supply chain
• Product diversion incidents in which a genuine product is fraudulently diverted and sold in a different market than intended will be greatly reduced with serialization
• Inventory management of both finished goods and consumables will be enhanced

Seek Improvements

As you embrace the changes that serialization brings, seek process improvements, particularly at an equipment level on your packaging line. Fix what needs to be fixed; engage with operators and technicians and listen to their feedback; involve a wide team of people and communicate with this team frequently. Don’t just view serialization as an “add on” to your existing process — challenge the status quo, encourage innovation, think about how things can be improved, and become leaner and smarter in the process.

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 work, which can lead to a behavioral and mind set change. Fundamentally, serialization is a soon-to-be mandatory requirement in most of the world’s biggest markets. The message is simple: to continue doing business, you must comply. At the core of this is patient safety — arguably the biggest business benefit of all to be gained from serialization.

About The Author

Yvonne 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.

Enterprise System Partners (ESP) is a leading global consulting and project engineering company – supporting manufacturing IT solutions for the life science industry since 2003. ESP offers 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.