Product inspection and control

 
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SERIALIZATION & AGGREGATION

At Glance

According to World Health Organization (WHO) and US Food and Drug Administration (FDA), the level of counterfeit products have reached its dramatical level. Drug shortages, price competition, demand for generics, and increased online buying further fuel the sale of counterfeit drugs. Drug quality directly impacts successful treatment of the patients, decreasing health risks and, damaging the brand image of the already struggling pharmaceutical industry.

In this regard, more and more countries require extensively implementing of the solutions, that secure people’s health and improve overall climate in Pharmaceutical Industry.

In terms of software and protection of the medicines, products must be equipped with unique code, as well as properly packed and tracked by a suitable data structure. In addition, the distribution of products must be tracked so that their authenticity can be verified when they are distributed and any irregularities can be accounted for.

System solutions

TRACK & TRACE (T&T) is a solution that can help pharmaceutical companies effectively manage their supply chain and mitigate the risks associated with counterfeit drugs. No doubds, that pharmaceutical industry meets a chalange, related to a comprehencive system solution implementation to the existing or new production lines.

The key to insure, that original drugs will reach the pacient is a SERIALIZATION PROCESS. In general requirements, for each country the serialization process is required. Serialization is tipically apply to all drugs, regardless of type and packaging size.

SERIALIZATION – is the assigning of a unique serial number to each produced unit of drugs, which is linked to information about the product’s origin, manufacturer and othe valuable data. Implementation of the serialization, securing that only original drugs will be presented on the market and eliminating a risk of double supply of the products with exceeded expired date.

Serialization is a part of the aggregation process, which includes marking (or unique number assignment) the individual unit. This includes the identification of the packaging system, boxes, pallets with the assignment of the serial number.

AGGREGATION is a process, that builds the relationship between individual units with drugs that assigned to packaging case boxes. If the case box consists of individual units with their own unique serial numbers, aggregation enables to associate »child« units with their bundle or case box »parent«.

Having aggregation on the production, let the manufacturer scan the case boxe's codes and even pallets, to track it's products through warehouse to distribution network and even till pacient.

Advantages

An appropriate Track & Trace system, including serialization and aggregation processes, can benefit pharmaceutical companies in different ways.

Brand Protection

Investments to whole solution of T&T system insures that manufacturer Brand name will be secured, as the trust to the producer will be incresed and safetz of the pacients will be protected.

Product Authentication
Serialization can prove a products authenticity, which means a manufacturer can detect and combat counterfeit products and ultimately protect their company brand.

Increase Supply Chain Efficiency

T&T solution accumulates business intellegent data, that can supports company to increase sales and make processes more effective. Analyse and lowering the costs by making the whole production work in the most efficient way. Analysis of the data can provide a detailed view on best sold product categories, optimize components delivery from suppliers, optimize deliveries.

Ensure Revenue Growth

Pharmaceuticals companies already investing in T&T solutions to reduce the extensive amount of counterfeit drugs, by tracking original products along the channels, avoiding theft, substitution, etc. In addition, pharmaceuticals taking an effort to own an advanced authentication features on packaging. By protecting the brand from counterfeit, companies increasing corporate revenue .

Meet Global and Local Requirements  

Every country that currently has a law on serialization has at least one additional requirement related to T&T, verification (the process by which product must be verified at one or more stops along the production process) or data reporting (to responcible goverment agency or other supply chain partner). Obviously, regualtions that are already exists will be developed further in a way to track and secure the data, control the flow of drugs through the channels. Some of the countries, requires reporting to the Goverment operator or database, or national catalog.

Some of the Global pharmaceutical companies are already investing to the complete solution, becasue of the cross boarder sales. Complete solution helps them effectively manage their supply chain process globally and meet all necessary requirements, that can appear.

 

INEL – Industrial Electronics, providing efficient, responsive to new global market challanges machines and software for Track & Trace solution, including serialization and aggregation.

Our top quality solution can be adopted and customized for special customer requirements.

INEL is a global supplier, who offers a comrehensive solution for pharmaceutical and other industries, that empower (or allow) companies to make a structured and efficient production processes system from Level 1 to Level 5.

Level 1: Devices level

INEL high quality machines for the serialization and aggregation are equipped with different hardware devices and sensors for performings, safety and other process operations on the production lines.

Level 1 defines layout and manages an appropriate communication betweern that hardware devices (such as printers, cameras, vignette and tamper evident labelling systems).

INEL Level 1 dedicated programmable line controllers (PLCs) to manage the serialized data at each stage from primary to palletization packaging, and send the printed and verified data to the Level 2 Line Controller where the required »parent« - »child« relationship is created and managed.

Level 2: Line Controller

INEl Level 2 is a line controller software for serialization and aggregation processes that manages one or more Levels 1 and connecting them to Level 3. Its and HMI Station that receives work orders from Level 3 and proceed them to machine line.

INEL has developed a user-friendly application that processing the right information to the right tabels to proceed the line with serialization and aggregation events.

We have developed unique solution that can be customized based on th regulations, requirements or customer's specifics. INEL software can communicate with Level 3 (custom made software) or Level 4 directly.

INEL supports its application in any critical situations and provides it's customer the most efficient and latest technological solutions.

Level 3: Site (Plant) Level

INEL L1 and L2 supports Level 3 to manage the processes on the production plant level. Site (Plant) Level is a software that maintaine unique code status, their distribution and manual/automatical status change.  It can control different lines in the location and manage the data for the whole facility.

Also, Level 3  provides interface to higher manufacturing execution systems like ERP, SAP, 1C and etc.

Level 4: Enterprise Level

Enterprise level manages the process on company level, no metter is it local or global company. It manages all the required data and business processes, manufacturing results related to serial numbers, inputs and outputs, batch data and recalls, storing and forwarding information, reporting.

Level 5: Network

Level 5 is an external level, which allows to report a determined infromation to a country-specific portals (drug agiensys; national catalogs and etc.), as well as share regulatory data with partners, distributors and third-party logistics providers.

Level 5 is also a supply chain for Track & Trace serialization data event bank.

 

From Level 1 and through the whole process of serialization and aggregation, decision that you make have an impact for the operation and efficiency of your company, your partners, suppliers and customers. Thats important to keep on top of mind , while deciding on the best systems-suited solutions for your business. 

INEL developes softwares and technologies to help Pharmaceutical companies and manufacturers to meet local and global requirements for serialization and aggregation processes.


We share passion for innovation!

 
 
 

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