Serialization & Track and Trace Solutions
SERIALIZATION, TRACK AND TRACK, AND ANTI-COUNTERFEITING PRODUCTS, SERVICES, WHITEPAPERS, AND ARTICLES
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Serialization Strategy 101
A step-by-step guide to implement track and trace.
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Visually Clean And Beyond
Implement a robust cleaning and sanitization program to ensure the safety and quality of personal care and cosmetics products while complying with global regulations.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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Pharmaceutical Labeling Systems For Vials
Vial labeling demands precise, high-speed labeling systems to ensure accurate and reliable product identification, particularly in the pharmaceutical industry where safety and compliance are paramount.
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Equipment Validation In The Pharmaceutical Industry
Equipment validation ensures pharmaceutical equipment meets regulatory and quality standards. Explore how a structured process ensures compliance, reliability, and high product quality.
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Consulting Services For Track And Trace Technologies
The counterfeiting of pharmaceutical products is one of the most significant tasks facing pharmaceutical packaging companies. Discover consulting for your supply chain that ensures compliance and enhances traceability.
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MHRA Provides Details On Windsor Framework For UK Medicines
With the Windsor Framework implementation date looming, Northern Ireland will now have its own regulatory authority for medicines. But what does this mean for patients, manufacturers, and distributors?
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Navigating EU GMP Annex 1 Revisions In Drug Manufacturing
Explore changes introduced by the revised EU GMP Annex 1, key considerations to maintain compliance, and stark statistics that underscore the consequences of non-compliance in this evolving landscape.
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Supply Chain Management Consulting Services
The restrictions of serialization requirements of various national authorities go beyond the production and packaging of pharmaceuticals - new processes are introduced into the logistics as well.
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Increasing Drug Manufacturing Efficiency With Intelligent Master Batch Record Design
Discover how to enhance your pharmaceutical production efficiency with an intelligent MBR design that offers tailored software, handling systems, and inspection machines.
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Controlled Substances In Clinical Trials
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
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Beginner's Guide To 21 CFR Part 11 Compliance
Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. While Part 11 is widely known, this blog explains how it fits in with your research software.
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A Guide To Pharmaceutical Cold Chain Management
Pharmaceutical cold chain management ensures temperature-controlled storage and transport of sensitive drugs. Learn about the key freezing ranges and their importance for various biopharmaceuticals.
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Why Compounding Pharma Manufacturers Should Evaluate BFS Systems
Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.
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Work With An In-Country Depot For Efficiency And Compliance
If you’re launching an international clinical trial, consider the noteworthy benefits of partnering with an in-country depot, including increased efficiency, reduced costs, and reliable access to raw materials.
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Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret Weapon
The current geopolitical climate is leading drug developers to consider global manufacturing partnerships strategically. Identify a CDMO partner that will help protect your IP, save money, and mitigate risk.
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Singota Solutions Unveils Strategic Approaches For Accelerating Drug Product Supply At Second Annual Capacity And Capability Update
Delve into our commitment to leveraging extensive expertise and capabilities to advance drug development processes and ensure that clients can navigate the pharmaceutical landscape successfully.
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ICH Guidelines: Challenges And Solutions For Pharma Manufacturers
Take the next step in enhancing your pharmaceutical manufacturing processes by investing in a robust quality management system (QMS) designed for ICH compliance and operational excellence.
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Extractables And Leachables Testing
Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process.
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Outsourcing Your Highly Potent Oncology Drug Product
Precision oncology treatments require specialized manufacturing and packaging, leading companies to outsource production. Assessing a CDMO’s highly potent processing capabilities is critical.
PHARMACEUTICAL SERIALIZATION & TRACK AND TRACE
In order to meet U.S. Food and Drug Administration standards for prescription drugs all drugs must have a drug pedigree. Currently most pedigrees are e-pedigrees, an electronic document that fulfills the Food and Drug Administration pedigree requirement. The purpose of requiring a drug pedigree is to protect consumers from counterfeit drugs or contaminated drugs.
Serialization, tracking and tracing is the primary way companies account for every product through every step of the supply chain down to the unit. Omega is only one example of a packaging system that allows tracking of individual packaging units using a unique ID on the bottom of every container.
The container un-scrambler allows full control over the containers as they pass through the printing, verification and rejection stations. This means every container has a readable container ID marking that can be used to track the product throughout production.
Downstream, containers receive larger, permanent fully serialized labels. Once the labels are applied to the container a camera using a serialized software management system syncs the label code with the container ID.
When containers are aggregated for final packaging, a shrink-bundler groups and wraps containers into a bundle. Container ID’s are visible through the bottom of the shrink-wrap.
Each bundle is passed over a camera system, which reads the container ID’s and identifies the containers in each bundle. A new label is placed on each bundle to establish the parent-child relationship making it easy to track and or trace an individual container or a bundle of containers.