Serialization, global pharmaceutical track & trace and Tien Tuan solution
The pharmaceutical industry has always faced many challenges – patent barriers, regulatory compliance oversight, as well as complex supply chains. Pharmaceutical products go through a distribution process from the manufacturer, the distributor, the dispensers, and finally the patients. Besides, drug shortage, cost-cutting pressuress, demand for generic drugs, and the increasing online buying activity (due to the Covit-19 epidemic) further promote the penetration of counterfeit drugs. According to WHO estimates, nearly $40 billion is lost each year to counterfeit products. Not only economic losses, counterfeit drugs also increase health risks, lead to drug recalls, and tarnish the brand image of the struggling pharmaceutical industry.
In an effort to support the control of counterfeit and fraudulent drugs, many solutions have been proposed.
One of the measures the industry took to overcome this challenge was to implement pharmaceutical serialization to protect the consumers; which in turn made it more difficult to manufacture fake goods. Serializing a product is only the first step to strengthening the supply chain. Track & Trace involves putting in place measures to identify the product and see its journey within the entire supply chain in order to reduce counterfeit and stolen products.
What is Pharmaceutical Serialization?
With pharma serialization, each product is assigned a unique identifier (UID). As the laws are different in each country, the regulations are defined on this basis. In certain countries the entire product dose may need to be serialized while for some countries the regulations may include even the smallest commercialized or manufactured unit in its regulations depending on the prescription drug batches. Often manufacturers have set requirements to follow, unlike the requirements in place for companies that are based on the country they’re selling their products in. For example, if a company is based in United Kingdom and sells its products in China, Saudi Arabia and India, the regulatory requirements will be different in each country.
What is Track and Trace?
Track and Trace is a new solution that can help pharmaceutical companies effectively manage their supply chain and mitigate the risks associated with counterfeit drugs. The track and trace technology enables manufacturers to monitor and track the whereabouts of their product in the supply chain and shipping; refers to the process of determining a drug's current and past locations. When track and trace is correctly implemented, a drug can be tracked throughout the supply chain and traced back up the supply chain upon return or recall.
Not every country with serialization requirements has track and trace requirements, but many countries are starting to implement track and trace paired with serialization to combat counterfeit, stolen or adulterated drugs. For instance, the U.S. is in the process of fully implementing the Drug Supply Chain Security act or DSCSA. The DSCSA details how the manufacturer must start the track and trace process through producing 3T data for drugs at the lot level. Every node within the supply chain from primary wholesalers and secondary wholesalers down to repackagers and dispensers must receive an electronic copy of the 3T data. They must also produce and add to the 3T data if they sell the product. Eventually, when all DSCSA requirements are fully implemented – recalled or returned drugs will be easily tracked back up through the supply chain.
As Track & Trace regulations vary according to each country’s laws, all products must first be serialized so they’re easily identifiable within the supply chain. Some of the additional requirements could also include reporting of the data to the respective governments and regulating bodies, verification of the products where the product’s serialized number can be cross checked with other data to ensure it’s an authentic product. Serialization requirements also need to take into account:
- The generation and format of the serialized numbers
- Aggregation of goods that can allow quick and easy scanning of products with their ‘parent vs child’ bundles,
- The guidelines to follow for packaging levels (primary, secondary and tertiary).
Track & Trace solution by Tien Tuan
In an effort to support serialization and track & trace for pharmaceuticals, Tiến Tuấn provides a wide range of comprehensive solutions, including hardware and software to meet requirements of global regulatory compliance.
Level 1: Print and check the serial number / batch number / expiry date / production date on the finished medicine box, save the data.
Level 2: Print and check the serial number of each layer of medicine box loaded into the carton and print the serial number of the carton, save the data.
Level 3: Print and check the serial number of the pallet loaded on the pallet and print the serial number of the pallet, save the data.
Besides, Tien Tuan also designs, builds and installs serialization as well as integrates control software from 2 blistering - cartoning lines or more; build a track & trace management system for the factory level as well as integrate additional track & trace management system for relevant parties such as processing partners, partners that keep drug registration numbers in the EU,...
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