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

Limited Lab Capacity? An Extended Workbench Program can help

Many small or virtual companies lack the square footage necessary to accommodate full-scale laboratories. To help alleviate this stressor, Alcami can dedicate its laboratory space and scientists to help ensure your project is a success and is completed on schedule. 

If you're challenged with limited laboratory space, let our scientists be your scientists with the help of an Extended Workbench program. 

Topics: News & Events

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

Alcami Participates in WILMA Dash and Health Fest

Alcami once again took part in the WILMA Dash and Health Fest on May 18, 2017 in Wilmington, NC. The event is the area’s largest all-female 5K race, featuring catered food, drinks, music, health screenings, fitness assessments, race awards, and much more.

Alcami is proud to have been a sponsor of this fantastic event. Special thanks to our ambassadors who helped further Alcami awareness in the Cape Fear region, and to our group of 5K run participants!

Topics: Blogs

ON-DEMAND WEBINAR: Get on Track with Serialization - Lessons Learned

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. 

Topics: Webinars Serialization Supply Chain

St. Louis Relocation Newsletter #3

Since January 2016, Alcami has been planning the relocation of its St. Louis site. The new facility, located at 4260 Forest Park Ave., Suite 201, St. Louis, MO 63108, will be part of the state-of-the-art Cortex Innovation Center. The countdown begins as we get closer to receiving the keys to our new facility.

In order to keep you updated on the development of our St. Louis relocation, we have created a quarterly newsletter that includes an overview of the relocation, information on site audits, a milestone schedule, and more. View the third edition of the St. Louis Relocation newsletter here.

Topics: News & Events

Extractables and Leachables – Why?

Regulatory agencies have become increasingly rigorous with regards to the detection, identification and quantification of extractable and leachable compounds in pharmaceuticals, drug delivery systems and biomedical devices. This increased scrutiny is the result of several well-documented incidents of contaminants leaching from containers and packaging, resulting in a potential or real risk to humans. 

Topics: Extractables & Leachables Blogs

Serialization Overview: What’s Required for November 27, 2017 Deadline

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.

Topics: Regulatory Compliance Serialization Supply Chain

Alcami Participating in Upcoming STEAM Train Express

Alcami will be participating in the upcoming “STEAM Train Express” event in Wilmington, NC. The event was developed through a partnership between the WILMA’s Women to Watch Leadership Institute and the Girls Leadership Academy of Wilmington (GLOW). GLOW is a single gender 6-12 charter school that focuses on college and career readiness, and emphasizes the importance of science, math and engineering.

Topics: Blogs

Bringing the Light to Photostability in Three Parts - Part Three

Part 1: Basic Requirements – Setting the Stage

Part 2: Forced Degradation Studies to Support Photostability

Part 3: The Protocol Generation - Execution and Reporting of a Photostability Study

In this third and final section of our photostability series, the protocol design, execution, and reporting of the confirmatory photostability for API and pharmaceutical products will be discussed.  ICH guidance Q1B presents a straight-forward flowchart that initiates with the direct exposure of the dosage form. To initiate a study, a protocol should be written based on the steps outlined in the flowchart. However, not every step in the flowchart is needed. 

At this point in product development, it is very likely that the photo-sensitivity of the API is known. If the API is photo-labile, a prudent step would be to write the protocol to direct exposure of product and exposure of the product in its immediate packaging would occur simultaneously. Not only would this save time, but would demonstrate the effect of the immediate pack has in protecting the product from photo-degradation. On the other hand, if the API is photo-inert, the direct exposure of the product may be the only exposure required. As stated in the guidance, each exposed foil-wrapped dark control sample should be exposed and tested. 

Topics: Stability Blogs