There are global public health threats and risks of falsified and counterfeit drugs in the pharmaceutical sector. Such falsified drugs might be actively dangerous as compared to their effectiveness and triggering adverse responses on the body or even death.
Moreover, these medications might be manufactured in numerous areas. For example, the chemical synthesis of these counterfeit in one area or country, the further procedures, and fillers done in another country. In the last, the packaging in a third country. In this way, it’s quite complicated to monitor these drugs and eliminate them from the supply chain.
The DQSA Law for Counterfeit Drugs
In the US November 2013, the DQSA law was signed to reduce the expansion of such counterfeit drugs. In the Drug Quality and Security Act, they ensure the ways to maintain an electronic system to recognize and also trace prescription drugs. Also, investigate and track the means of production of such drugs.
The DQSA rules are for
- The wholesale suppliers of counterfeit drugs.
- The dispensers of counterfeit drugs.
- The logistics service providers of counterfeit drugs.
- The distributors of counterfeit drugs.
- The wholesalers of counterfeit drugs.
- The producers of counterfeit drugs.
- The manufacturers of counterfeit drugs.
Let us discuss some standard fundamentals of the serialization process and the challenges that occurred in the Pharmaceutical Serialization Solutions.
Serialization- A Solution to Get Rid of Counterfeit Drugs
Serialization is the providing of a distinct identification serial no. to each unit of each prescription item, which is on sale in Pharmaceutical markets.
Serial number to each drug includes:
- Data about the drug.
- The batch no. of that drug.
- The manufacturing origin of that drug.
- And the date of expiration.
The DQSA instructs that from November, all prescription medications offered in the US need to be serialized at all levels.
Process of The Serialization
The SNIs system is introduced for the serialization process, which is proposed by the FDA to tackle this situation. According to standard numerical identifiers, (sNDC) is allotted to each drug unit before the packaging process. A specific serial number assigned to each manufacturer’s drug unit, i.e., serial serialized national drug code. Drug producers can give these serial number codes—a 2D barcode on the tag of each shipping level units and commercial unit.
The Serialization Code
To verifying each serialization code, the product packaging line checks each label to notify each unit. A temporary code printed in UV ink on the top of each product’s lids manages the scanning process as the bottles are not evident in the cases. This is called the topset.
Huge suppliers hypothesize that the FDA will certainly soon require the collection of serialization data and verification regarding which serial numbers standard numerical identifiers (sNDC) in each case, pallet, bundle, and each drug, which were sent to each pharmaceutical stores.
In order to ensure these serial numbers to every delivery, it is required that suppliers double-check the information throughout the ways. In the next step, this information will be sent to (ASN) the advance shipping notice to ensure all serialization solutions. For FDA audits these all rules need to retain the details.
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Pharmaceutical Serialization Solutions Approaches
Below are some Pharmaceutical Serialization Approaches
Serialization solutions have some challenges at many different points in pharmaceutical manufacturing.
Monitoring and Schedule of Date at Big Scale
There is a need for management of these product units’ data along with apparent product packaging modifications. There is a demand for IT management to build a huge system of millions of serial numbers to deal with multiple supply chains at once.
Restructured the Label
A specific redesign of labels is required for serialization solution 2D barcode to ensure the quality of drug units. Similarly, modifications in labeling might additionally demand modifications or restructuring of the graphic and packaging of products.
Cost Serialization Startup
Serialization needs a specific significant investment to manage initial costs, develop hardware and software programs, update existing tools, and start training. Although, in international pharmaceutical markets, these expenses are required to continue conducting service. But the main issue is how these expenses will certainly be passed along to the consumer is still to be set on.
Serialization Team for Multiple Functions
The serialization solution has IT specialists in processing a vast Serialization system. They manage the quality control of products, labeling, design, and task monitoring should coordinate to ensure a smooth platform. The Serialization solution built both data management and manufacturing systems.
Enhance Your Supply Chain with the Serialization solutions.
To improve your production goals, everyone needs to follow the certified serialization options and develop a systematic serialization solution. The well-organized serialization solution will minimize counterfeiting and enhance clarity. Moreover, the serialization solution helps the supply chain partners get rid of defective and recalled drugs faster and increase the shipping rate.