The United States enacted the Drug Quality and Security Act (DQSA) in November 2013 to combat drug counterfeiting. The first part of this act is a federal framework that addresses the quality of medicines, and the second part addresses the safety of the supply chain. In this article, we will explain how the second part of DSQA can be implemented in accordance with the requirements of the Drug Supply Chain Security Act (DSCSA) 2023. However, in order to better understand the DSCSA’s 2023 requirements, we first want to explain DSCSA’s milestones with a timeline.
Solutions Including Aggregation for DSCSA 2023
Timeline of DSCSA
2023 Requirements of DSCSA
The pharmaceutical industry of America completed the serialization of all drugs project in 2017-2018. The next most aggressive challenge is to ensure that serialized drugs are traceable within the supply chain. Serialized drugs need to be aggregated to make sure that the drugs are traceable in the supply chain. In addition, pharmaceutical manufacturers are required to install a VRS (Verification Router Services) system.
Aggregation for full compliance with DSCSA
Drugs on the US market and transport units that integrate these drugs (container case, bundle, pallet) have been serialized. But the DSCSA wants hierarchical aggregation of transport units. What does this mean?
In short, aggregation in the pharmaceutical industry is defined as the virtual connection of serialized transport units and serialized drugs within them. The most common method for this virtual connection is to create a hierarchical data with a parent-child relationship. When this data is associated with the serialized transport unit, the aggregation is complete.
Verification Router Services Installation
Each drugmaker is required to install a VRS system following the standard published by GS1. Thanks to this system, distributors, pharmacies, and end-users will be able to question whether the drug is counterfeit. The FDA and the pharmaceutical industry, which are currently conducting pilot studies, are expected to announce the results of pilot studies for VRS shortly.
VISIOTT, which has been producing machine solutions for serialization and aggregation of drugs for 15 years, helps keep your drugs traceable with Level 3 and Level 4 software solutions that follow DSCSA requirements. By filling out the contact form, you can contact our local sales team and ask our experts all questions you are interested in.
Bottle Serialization and Aggregation in accordance with DSCSA
Serialization in bottles used in the American pharmaceutical industry is carried out on the label on the bottle. Thermal printers integrated into labeling machines are the most commonly used method to meet this requirement. Applying a helper code to bottles to meet the aggregation requirement and matching this helper code and the code on the bottle is a common method. The most common method for matching the helper code with the code on the body is 360-degree decoding. After matching, the aggregation process can be easily completed by reading the helper codes on the bottom or cap of the bottles collectively.
For VISIOTT’s bottle serialization and aggregation line offering in accordance with DSCSA requirements, please see the specifications of the stations below.
Carton Serialization and Aggregation in accordance with DSCSA
Cartons are easier to serialize than bottles. Because printing is done on a flat floor, and there is no need for a helper code for aggregation. Codes can be read collectively with a high-resolution camera.
There are also many technological alternatives to printing 2D code on cartons. Thermal Inkjet and Laser are the most commonly used technologies. Especially with advanced thermal inkjet technology, almost any surface can be printed with water and solvent-based inks. Thanks to our high-speed camera technology, you can perform 2D code control at 600 box minutes.
This machine carries out the serialization of cartons widely used in the pharmaceutical industry. Also, it takes up small space on your production line with its optimized design. Integrated with pharmaceutical production lines, it can serialize at the speed of 400 cartons/minute.
The system used for the serialization of the cartons is also capable of tamper-evident labeling. Besides, the station meets the market needs which have a tamper-evident obligation such as Europe and Turkey.
You can use this machine if you can’t carry out aggregation operation automatically. Also, you can carry out the fastest aggregation possible with an extensive reading area and fast code analysis algorithm. Furthermore, you can easily relocate it on the production area thanks to its wheeled design.
For VISIOTT’s carton serialization and aggregation line offering in accordance with DSCSA requirements, please see the specifications of the stations below. You can contact our sales team for more detailed information.
Author: Emre ÖZDEN