Excerpted from Pharma's Almanac roundtable discussion in their Q4 2020 edition.

Although there is no such thing as a truly “crisis-proof” organization, how are you working to mitigate risks for future crises like the COVID-19 pandemic?

We’ve learned this year to expect the unexpected, and I don’t think any organization can be 100% “crisis-proof.” Still, at Alcami, we work very hard to be proactive and prepared for anything that may come our way. This effort applies beyond natural disasters and force majeure events to anything that may not go as planned. I’m confident anyone working in drug development would agree; unforeseen challenges will inevitably arise somewhere along the way.

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 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.

New requirements under the Drug Supply Chain Security Act (DSCSA) have been set for manufacturers, repackagers, wholesale, distributors, dispensers and third-party logistics providers. Some of these requirements began in 2014 with additional requirements continuing to be phased in until 2023. The November deadline is part of the multi-year initiative to secure the supply chain for pharmaceuticals in the U.S.

The goal of the DSCSA is to enable tracking of drug product down to the individual unit of sale and to improve detection and removal of counterfeit products in the drug supply chain along with facilitating more efficient drug recalls.