Traceability Solutions aids in the prevention of counterfeiting of Pharmaceuticals
Issued by TracePack - Jul 4th 2018, 15:21
The counterfeiting of pharmaceutical products is an enormous risk for consumers’ health and a major economic loss for the pharmaceutical industry. The safety of pharmaceutical products is a necessity for the final consumer and it requires an utmost control of the flow of products, from the manufacturing to the distribution.
In this context, many countries have decided to adopt new regulations with the aim to introduce safety elements for the packaging of medicinal products for human use. This is a significant change that will ensure the authenticity of medicines and safety for patients (and also for the pharmaceutical industry) and will strengthen the security of the supply chain.
One of the components of anti-counterfeiting is the process of identifying every individual package, which passes under the concept of serialisation. Each package will be coded with a 2D code (GS1 Data Matrix) containing a unique identifier. The data must also be printed in human-readable format and if possible adjacent to the two-dimensional barcode containing the unique identifier.
In addition to the unique identifier, the integrity of the tamper prevention system ensures that the packaging has not been opened or altered after its release from the production facilities, thus ensuring the integrity of the contained drug. Currently, the needs for serialisation are limited to the marking of the unique code on the single product sold. However, from now, each product must be traceable to the entire supply chain: individual packaging, box/pallet, final distribution point. This level of serialisation is called aggregation.
The European Directive on Falsified Medicines (FMD) makes the serialisation and tamper-evident processes mandatory for every drug that will enter the European single market from February 2019. For this reason, even some non-EU member countries have decided to adapt to the FMD. In general, every pharmaceutical manufacturer will be required to comply with the regulations of the markets in which he wants to sell his products.
For this reason, pharmaceutical companies that export their products abroad are subject to these regulations even if the serialisation is not yet regulated by their local legislation. The regulation defines which are the characteristics of the UNIQUE IDENTIFIER that have to be marked on all the boxes.
The identifier will be composed of readable and two-dimensional formats, depending on the destination country and its specific rules. It will have its own communication process to a multilevel storage structure in order to allow its verification.
• A code that identifies the common denomination, the pharmaceutical formula, the dosage, the size and the type of packaging;
• A numeric or alphanumeric sequence of no more than 20 characters, generated by a randomisation algorithm
• A national reimbursement number or other national number identifying the medicine, if required by the member state where the product is destined to be placed on the product;
• The lot number
• The expiry date
In order to mark the Unique Identifier directly on the pharmaceutical carton, there are two main techniques that can guarantee excellent marking quality while maintaining high productivity:
Currently, the most used solution by pharmaceutical companies is inkjet marking. However, companies that decide to rely on laser marking are increasingly frequent, thanks to a series of very interesting and competitive advantages:
UNMATCHABLE PRODUCTIVITY: thanks to the possibility of continuous operation, with no down time for replacing consumables.
INDELIBLE: laser marking is forever.
COST EFFICIENT: lasers don’t require any consumables.
HIGH GRAPHIC QUALITY that is always absolutely constant over time.
ECO-FRIENDLY: lasers don’t produce any residual waste.
The anti-counterfeiting regulations do not indicate a specific methodology for the realisation of the integrity of the packaging. The available systems include pre-cut and glued cartons boxes, tamper evident security labels, wrapping the entire package in a sealed film, using specially designed folding cartons. The solution most used by the pharmaceutical industry is the application of self-adhesive Tamper Evident labels.
The two most common TE techniques are:
• Wipe Out: anti-counterfeiting seals/labels produced with destructible materials, the labels break in different pieces when lifted from the product or the surface on which they are stuck avoiding the new repositioning.
• Void seals/labels: anti-counterfeiting seals/labels produced with special materials and adhesives; when lifted they leave on the products an evident customised writing avoiding the repositioning.
Tracepack can offer pharmaceutical manufacturers the following products to guarantee the “secure conditions” imposed by the directive 2011/62/EU:
• Tamper evident labelling systems
• Tamper evident labels
• UV inkjet systems and UV Ink
• UV Thermal Inkjet cartridges
• Taggants and Micro Tracers
• Laser Additives
Click here for more information on Mitas
Cosmetics and personal care items are among the fastest growing industrial sectors globally. In this highly competitive market, manufacturers are looking for ways to differentiate their products through innovative packaging to enhance brand image. Manufacturers of personal care products (cosmetics, perfumes, dental products, shampoos, personal hygiene products, etc.) must code the packaging of their products according to legislation.
While most fakes and counterfeits have typically been manufactured in China, other regions like India are also a common place for counterfeits to originate from. These days, it’s becoming more common to see counterfeiters working in countries where they operate.
Inspection is part of the overall drug quality assurance system. The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP) compliance or to provide authorization for the manufacture of specific pharmaceutical products, usually in relation to an application for marketing authorization.
In the pharmaceutical manufacturing environment, it is absolutely critical to managing environmental conditions. Currently, this is done either manually or with bespoke solutions that have been very expensive and intrusive. Additionally, the mechanical equipment that is currently used, requires annual maintenance and calibration. This process is very expensive and resource intensive.