Our dedicated team work with each and every client to understand the requirements, research solutions and provide a bespoke solution based on need. Data is shared between trading partners along the supply chain. The information required in a serialization program is strongly dependant on the many different national laws and standards. A large number of industries benefit from serializing their products — any industry in which counterfeit products are a problem will appreciate serialization's anti-counterfeiting capabilities. There is still no global standard for consumer protection regarding prescription medications. The system provides maximum flexibility in ensuring the continuity of the serialisation right up to the last level of aggregation. They will be at your side during order processing and subsequently help, together with our service department, during implementation in your production lines.
Postponing the date is also intended to prevent disruptions to the supply chain. Serialization could potentially identify every product by a unique serial number in addition to the origin, shelf life and batch number for that product. In this way we ensure that the agreed product and customer-specific requirements are met and completion is on schedule. For producers of pharmaceuticals this means that anyone not complying with the requirements for pharma serialization will no longer be able to sell medicinal products on the European market as of 2019. The interoperability standards created as a result permit data exchange and collaboration across many systems. The accumulating volume of data has to be centrally stored in cross-company databases.
We would like to let you know that some features on the site may not be available or may not work as nicely as they would on a newer browser version. To facilitate German drug manufacturers in implementing a practical and realistic solution, diverse pharmaceutical associations, the wholesalers association, and association of pharmacists joined together to form securPharm. The auxiliary code is used for aggregation in bundles or cartons. Figure 2 As shown in Figure 2, the implementation of the act is phased. It ultimately depends on this whether a product is saleable at all.
The complete supply chain is traceable, transparent, and secure. The philosophy of short chains is what ensures the greatest flexibility in implementing each individual product configuration. This process of Serialization is geared to verify and identify, not only on a unit level e. A product may bounce around multiple distribution centers before changing custody with each location and provides an opportunity for counterfeit product to enter the supply chain. We will give our very best to support you. What industries can benefit from the serialization process? They weigh the pharmaceutical product on the same installation surface and thus carry out a simultaneous package completeness check.
A number of countries across the globe have requirements mandating the serialization of pharmaceuticals. An estimated 80 percent of counterfeit drugs come from overseas with most of them manufactured in India and China. Serialization machines print drug packages with the necessary codes for serialization: Depending on the guideline, these are machine-readable matrix codes or alphanumeric character strings. Through the use of integrated and multilayered technologies a systematic methodology has been undertaken to combat counterfeit drug products, thereby allowing for validation of the integrity of each drug package delivered to patients. Integrated Tamper-Evident for tamper-proof locking.
Our experts for the serialization and aggregation of pharmaceuticals have collected for you all relevant data such as national regulations, underlying coding requirements, implementation deadlines and evaluations of the market situations in relation to future developments. They therefore had less than two years to implement a serialization solution. It also states that the current federal pedigree requirements as defined under the Prescription Drug and Marketing Act 1987 must continue in force until Jan. Simply click on a country to get all the relevant data on the global pharma serialization and aggregation requirements. Fully integrated lab printer including camera control. While there has been general agreement amongst all states within the U.
A completely controlled production flow can still fail right up to the last stage in the product design process, possibly the palletizing of individual boxes prior to shipping. Our international activities also provide our customers with additional benefits. Click Here To Download: In an effort to combat the risk of counterfeit and adulterated drugs, national regulators have pursued the need for product serialization. Whether you need to comply with serialization regulations on product traceability, protect your brand from product diversion or counterfeits, create a unique link with your consumers or patients, we can deliver! These numbers are usually printed on the surface of the packaging or on a label which is then applied to the package in both human and machine-readable formats usually a 1D or 2D barcode. The majority of countries in the rest of the world are currently working on more binding legal texts, which heralds the start of the hot phase of implementation running up to a fixed date. Unreadable or invalid serial numbers lead to the ejection.
This ensures complete serialization at every level. In particular, due to the quality and flexibility of our space-saving system, we do not need to be concerned about any of the global marking requirements to be expected in relation to future export to the Far East. Figure 1 Pharmaceutical companies and governments worldwide believe that counterfeiting can be reduced significantly by implementing product serialization. It may also be necessary to scan products along each step of the supply chain, depending on regulations. Turkey, for example, is thought of as a pioneer and, since 2010, has had legislated controls of the complete supply chain. The individual packages are additionally packaged so as to be tamper-evident.
Specifically, this means: Any drug manufacturer or contract supplier that does not intensively come to terms with this topic now, risks serious consequences in the future - from delivery delays to the complete inability to deliver. The operation of the functional units for product handling, coding, and camera inspection is convenient and fully integrated in one software package. In the light that the world is facing a persistent and increasing threat from counterfeit, misbranded, adulterated, or diverted prescription drugs, government leaders, politicians and executives from major pharmaceutical providers are driving efforts to develop methods to reliably track and trace prescription drugs. It requires collaborative action from partners throughout the supply chain for accurate recording, tracking and managing of data as the product moves from manufacturer, to distributor, to the dispensing point. Ejection of missing or incomplete packaging. Thanks to the compact design of the labeler, a tamper evident label can be applied to prevent illegal opening of the original box. Handscanner to query and change the aggregation hierarchy.
Broadly speaking, two serialization models are emerging. Pre-serialized bottle or vial labels are verified. Our current customers include well-known, demanding pharmaceutical companies. We will not share your personal information with non-agent third parties. Our solutions for serialization and aggregation combine machine-readable product codes and unique product assignment thanks to serial numbers. This is particularly useful in the electronics and pharmaceutical industries, as well as for luxury goods such as premium alcohols and even caviar. This not only includes item level serialization, but the application of additional anti-counterfeiting measures such as tamper-evident seals.