Since the Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013, Serialization (also referred to as Track and Trace) has become a popular topic in the pharmaceutical industry, not just in America, but globally. Over 40 countries today are working on track and trace laws and regulations to help secure pharmaceutical products supply around the world.
When discussing Track and Trace, Track means that the end user can understand the current and past locations of a serialized item in the supply chain. Trace means that there is a history of who came in contact with that item as it moves through the supply chain (Manufacturer, Wholesaler, Distributor, Retailer). This is achieved through a unique serial number being assigned at the unit (bottle or blister), case and pallet levels during packaging, that then will be transacted against during the movement and life of the product.
As the deadline to serialization approaches, many pharmaceutical organizations have been hesitant to implement serialization. According to a new study by SEA Vision and Zenith Technologies, more than half of industry professionals believe that the cost of implementing serialization is the greatest barrier to serialization compliance.
There’s more to serialization requirements than compliance. A strong serialization strategy can deliver valuable benefits to your organization.
Business Benefits Beyond Compliance
- Protection of Consumer Safety.
Avoid incidents that put patients at risk for treatment failure, harmful side effects, and even death, by protecting against counterfeit pharmaceuticals.
- Product Authentication and Brand Protection.
Digitally authenticating your pharmaceutical product allows the manufacturer to detect and combat counterfeit products as they travel through the supply chain.
The publicity of counterfeit medication can pose a threat to even the strongest brand names. By protecting your pharmaceutical product against counterfeiting, you’ll also protect your brand name.
- Coordination of Supply Chain Data.
Serialization allows manufacturers to gather information as each product moves through the supply chain. Better supply chain visibility can help control inventory and reduce costs due to product shrinkages/losses.
- Recall Integrity.
Errors in labelling have been a large factor behind pharmaceutical product recalls. Tighter process and validation controls, documented risk mitigation strategies, and enhanced technology can all help manufacturers reduce the risk of product recalls.
If and when an event occurs where you must recall your product in the market, a serialized system allows you to respond more quickly to situations as manufacturers are able to pinpoint the exact locations when counterfeit products are in question.
- Revenue Growth.
Greater supply chain visibility provides pharmaceutical companies with real time data, ultimately improving the accuracy of sales forecasting.
The implementation of Serialization is a complex project that could bring significant challenges to your pharmaceutical supply chain. However, with a strong serialization strategy to provide enhanced product security, pharma companies can provide safe, unadulterated medicines to patients, ensure business continuity, and safeguard your right to supply medications that meet regulatory requirements.
Are you interested in learning more about Bellwyck Pharma Services’ serialization capabilities?
Contact us today by visiting: https://bit.ly/2sUnyf4
Sources:
FDA – https://bit.ly/2tIy0b2
SEA VISION – https://bit.ly/2thQgGP
Pharmaceutical Online – https://bit.ly/2LhJGua
Logistics for the Life Sciences – https://bit.ly/2LvW5HE
Markem-Imaje – https://bit.ly/2zQYuLH
USDM – https://bit.ly/2LrCx7f
Packaging Digest – https://bit.ly/2rzmXw6
Adents – https://bit.ly/2LtVsi2
