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In the pharmaceutical industry, counterfeit and falsified drugs pose a global public health risk. These drugs may be not only ineffective but actively dangerous, causing adverse reactions or even death. Furthermore, these counterfeit drugs may be manufactured in multiple locations — e.g., chemical synthesis in one country, the addition of fillers in another and packaging in a third — making them difficult to track and remove from the supply chain.
To reduce the proliferation of counterfeit drugs in the U.S., the Drug Quality and Security Act (DQSA) was signed into law in November 2013. Title II of DQSA outlines steps to build an electronic system to identify and trace prescription drugs as they are manufactured and distributed. These regulations apply to manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers.
Here are a few basics to help you understand the relevant regulatory issues and the serialization process.
What is Serialization?
Serialization is the assigning of a unique serial number to each saleable unit of each prescription product, which is linked to information about the product’s origin, batch number and expiration date. The units can then be tracked through its entire supply chain — from production to retail distribution to the final dispensation to the patient. The DQSA mandates that all prescription drugs sold in the U.S. must be serialized at both the salable unit level and the case level by November 2017.
The Serialization Process
The FDA guidance recommends the use of standard numerical identifiers (SNIs), in this case, the serialized national drug code (sNDC), which is the NDC combined with a unique serial number. Serialization codes can be created either by the client or manufacturer, generated randomly or sequentially. After procuring the serialization codes, the manufacturer prints a 2D barcode on the label of each saleable unit and shipping case.
The packaging line scans each label to determine which unit goes into which case. Because each label isn’t visible as the bottles are lowered into the cases, each bottle also has a temporary code printed in UV ink on the top of its lid (or topsert).
It is speculated by large distributors that the FDA will soon require the collection of serialization data and verification as to which serial numbers were in each bundle, case and pallet, and ultimately which units were sent to each retailer. In order to have this information without reopening every shipping case, it is required that manufacturers aggregate the data throughout the process. This information will then be sent electronically in an advance shipping notice (ASN). All parties must retain the information for FDA audits.
By 2023, manufacturers must also implement an electronic system capable of tracing all packages of prescription drugs through the entire distribution chain.
Five Key Challenges in Serialization
Serialization presents challenges at many different points in pharmaceutical manufacturing.
- Label redesign
For many manufacturers, serialization will require a significant redesign of labels to allow space for the new 2D barcode. Consequently, changes in labeling may also necessitate alterations or redesign of packaging structure or graphic elements.
- Maintaining production efficiency
The new labeling requirements will have an impact on multiple packaging processes. Adhering labels and scanning bundles, cases and pallets will all slow down the packaging line. The manufacturer will need to increase manpower or automation to maintain current levels of production.
- Data management and availability
In addition to physical packaging changes, data management needs will grow rapidly. The IT architecture must be able to generate, store, capture and transmit millions of serial numbers for numerous supply chains.
- Assembling a cross-functional team
Serialization has both information and production-floor aspects. Experts from IT, processing/packaging, engineering, labeling, quality assurance and project management must cooperate to ensure a smooth implementation.
Serialization requires a significant capital investment to cover startup costs, updating existing equipment, hardware, software and training. Although these expenditures are clearly necessary to continue conducting business in global markets, the question of how these costs will be passed along to the consumer is still to be determined.
How Serialization Improves Supply Chain Security
Despite the challenges, clients can partner with CMOs to develop efficient, compliant serialization solutions that meet their manufacturing goals. When fully implemented, serialization will lead to increased transparency and visibility by reducing counterfeiting, diversion and theft. Furthermore, with the ability to trace product locations, supply chain partners can increase shipping accuracy and more quickly remove recalled and defective products.