There were some much-needed changes in the pharmaceutical sector over 2019, but what were they?
One of the biggest threats facing the pharmaceutical packaging industry in 2019 and 2020 is counterfeit and falsified products. They pose a massive risk to public health and safety around the world.
Counterfeit drugs are not only ineffective, but they could cause adverse reactions leading to serious injury and death. Not to mention the fact that many of these fake drugs are manufactured in third world countries without adequate facilities and quality controls and testing.
What Are Governments Doing To Stop It?
To help fight this flood of counterfeit drugs entering the global market, the United States Drug Quality and Security Act (DQSA) was signed into law. Part of the DQSA requires all companies involved in the manufacturing, repackaging, distributors, dispensers to track the pharmaceutical medication in their control.
Below we’ll outline the basic outline and requirements of the DSQA regarding serialization.
- What Is Serialization? – This is a unique serial number that is applied to every saleable unit of each pharmaceutical medication. It has to show the product’s origin, batch number, and also the expiration date — this way, the unit can be tracked from its creation through to the patient.
- What Is The Serialization Process? – The Food and Drug Administration (FDA) recommends the use of standard numerical identifiers (SNIs), in the case of pharmaceutical medication, a serialized national drug code (SNDC). The manufacturer is responsible for placing the codes on the drugs, but the codes themselves can be generated by either the client or the manufacturer.
It’s expected that by 2023, all manufacturers will be required to implement an electronic system capable of digitally tracking all their drugs throughout the shipping process.
What Are Some Of The Challenges Of Serialization?
Serialization is going to present some difficult, but not impossible challenges to the pharmaceutical packaging industry. While they may take some changes to implement, it’s believed in the long run that the new changes will help to identify the fraudulent pharmaceutical medication.
Some of the challenges regarding serialization are:
- Label Redesign – Serialization is going to require many manufacturers to redesign their labeling to allow space for the new 2D barcodes. This will have a flow-on effect on pharmaceutical packaging.
- Product Efficiency – Having to electronically scan and track all shipments, from individual batches through to bundles and pallets, will slow down the packaging line.
- Data Management – Companies will be required to create more detailed digital systems and networks to track and manage the required new data tracking.
- Additional Costs – There will be additional costs associated with implementing the new labeling and tracking requirements.
Content created by Mason Taylor, specialist and owner pharmaceutical packaging company.
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