Editorial: How to Find Your Secret Source

Alcami recently contributed to a special feature in The Medicine Maker magazine, titled "How to Find Your Secret Source."

Excerpt from Alcami: “I have a point of contention with the titles  ‘one-stop shop' or 'specialist supply chain’ because they imply that you can’t have both! If you have independent API and drug product, you can bring these together. Being that we were founded by merging two specialized organizations, we have experts in each area, which we then over arch with a structured offering to make sure they are properly integrated. A key thing our clients tell us – especially smaller clients who don’t want to manage a big supply chain – is that they like the internal efficiencies you can get with a one-stop shop."

Topics: Supply Chain Editorials

Beyond the Label: Four Challenges to Serialization

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.

Topics: Regulatory Compliance Serialization Supply Chain

Minimize Supply Disruption at Any Life Cycle Phase

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.

Topics: Supply Chain Blogs

How Risk Assessment and Planning Safeguard a Supply Chain

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.

Topics: Supply Chain Blogs

Identifying and Reducing Risks within the Pharmaceutical Supply Chain

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.

Topics: Supply Chain Blogs

ON-DEMAND WEBINAR: The Future State of Supply Chain Solutions

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.

Topics: Webinars Supply Chain

Editorial: Implications of Serialization for the U.S. Pharma Industry

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.

Topics: Regulatory Compliance Serialization Supply Chain Editorials

Serialization - Data Management Challenges

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.

Topics: Regulatory Compliance Serialization Supply Chain

White Paper: Guide to Pharmaceutical Serialization 2017

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.

Topics: Serialization Supply Chain White Paper / eBook

FAQs on What Happens If You Miss the Serialization Deadline

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.

Topics: Regulatory Compliance Serialization Supply Chain