Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a serialized label. These are, of course, very legitimate concerns. However, there are much more complex issues at hand, including the importance of standardization, scaling information technology infrastructure, agility to accommodate regulatory changes, and data security.

Why Serialization Matters
The first objective of any pharmaceutical company is to deliver safe and effective medicines to patients. While historically there have been methods to provide product visibility and control along the supply chain, the processes have been highly manual, with paper-based record keeping being the prevalent modality.

As supply chain complexities grow, risks can arise at every phase of the product lifecycle. From quality issues and drug shortages to new serialization regulations and natural disasters, today’s risks are significant and supply disruptions can be catastrophic. Alcami has been thinking extensively about what we can do to help solve this challenge.  As a result, we have created, Protect Your Brand^®, a unique offering designed to support pharma and biotech companies pursuing a dual source strategy.

Under this program, Alcami will support tech transfer and validation of products in advance of potential manufacturing needs without any long-term commitment or minimum annual volume. We have developed a process to systematically analyze and identify supply risks and to create a backup plan accordingly. We use our proprietary State of Alcami Readiness™ scoring system to assess and assign a risk level to the supply chain in question.

The risks within the pharmaceutical supply chain are many and varied. However, the risk level of a given supply chain can be assessed, and risk reduction and strategic readiness plans can be created. While it is impossible to mention all the possible supply chain risks within one article, the following two scenarios are very common.

Scenario #1
A small pharmaceutical company in the middle of late-stage clinical trials ran into a huge problem when it was uncertain whether or not their contract development and manufacturing organization (CDMO) could meet their resupply timelines due to capacity restrictions. The substantial market approval delay, which could result from a clinical trial delay, would threaten their funding and jeopardize patient access to this new medication.

For many years, pharmaceutical manufacturers have focused on increasingly stringent supplier certification requirements and other measures of this nature in attempts to reduce risk within their supply chains. Only in recent years have manufacturers recognized that they alone must own and manage the risks associated with their products in a manner that ensures the utmost protection for patients, maintains the integrity of their supplies, minimizes drug shortages, and achieves product development milestones.

Regulatory and quality violations within the supply chain, clinical holds, and capacity challenges represent the most significant risks to supply integrity that pharmaceutical manufacturers must manage.

Join Alcami for a webinar to learn more about the future state of supply chain solutions.

From quality issues and drug shortages, to warning letters and natural disasters, today’s risks are significant and supply disruptions can be catastrophic. Therefore, having a secondary supply chain “on-call” is a must. When developing this innovative dual sourcing strategy, validation of processes with a reliable and flexible supplier protects against supply interruption. Alcami has designed Protect Your Brand™, a first-to-market initiative, to aid in the protection of supply chains.

As published in Pharma's Almanac Q2 2017.

New requirements under the U.S. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. Some of these requirements began in 2014; additional requirements will be phased in until 2023. The next deadline — November 2017 — applies to manufacturers. Compliance is challenging, but noncompliance carries the risk of significant consequences. In addition, challenges won’t end with implementation: there will be vast quantities of data to manage to support serialized production moving forward.

The implementation of the Drug Supply Chain Security Act (DSCSA) requirements poses many challenges. There can be an impact on productivity if your Serialization and Track/Trace systems are not prepared. Poor implementation plans can cause operational bottlenecks for several years as additional requirements are steadily implemented from now to 2024. As each system goes online, it will be necessary to “work out the bugs” and provide additional training for production and warehouse personnel.

As required by the Drug Quality and Security Act (DQSA) signed into law by President Obama on November 27, 2013, serialization will be required by pharmaceutical manufacturers on all commercially distributed prescription human drug products effective November 27, 2017. 

This guide is designed to serve as a reference for the core information, issues, and questions pharmaceutical companies must address as they work with their CDMO and other members of their supply chain.

Serialization affects all stages of the supply chain and with many companies, small and large, unprepared for the scope of regulations and data support required it leads to the question: what happens if you miss the serialization deadline? This blog is intended to shed light on what to be ready for and what consequences will take place if you do not make the November 27, 2017 deadline.

Join Alcami for an on-demand webinar, discussing the challenges and complexities of serialization implementation.

As the pharmaceutical industry races to meet the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline, the challenges and complexities of serialization implementation must be understood.