One of the most important challenges facing the pharmaceutical industry is that of counterfeit medicines. Find out in this blog article how Macsa id can help your company reduce medicines fraud.
According to the World Health Organisation (WHO), this type of fraud seeks to imitate legal products as closely as possible in order to avoid detection. Fraudulent medicines may contain active ingredients other than those declared, with harmful substances and doses different from those authorised, have inadequate purity, or give false information on the identity and origin of the product, among other issues.
Generally, these types of drugs are manufactured without the required health authorisation, so there is no control over their manufacture and marketing, resulting in a risk to people’s health. Such risks have increased in recent years due to e-commerce and now affects both branded and generic medicines.
This fraudulent practice costs the pharmaceutical sector in the European Union (EU) 10.188 billion euros each year, representing 4.4% of the sector’s annual legitimate sales in the EU. This reduction in sales also translates into the direct loss of 37,700 jobs in the sector.
Guaranteeing the identification of fraudulent medicines through serialisation
TABLE OF CONTENTS
- Safe and legal medicines
- Global solutions for coding, marking and traceability for the pharmaceutical industry
- An end-to-end solution for FMD
- Printing and serialisation solutions in the supply chain
- Supply chain software solutions
- SERIAL FARMA’s main functions
- Macsa id, the expertise of a market leader in coding
Safe and legal medicines
To ensure safe and legal development of medicines and their manufacturing process, the European Union has the Falsified Medicines Directive 2011/62/EU (FMD), which aims to prevent the entry of such products into the supply chain and to identify them where they are present.
This directive, which has been mandatory since 2016, establishes solutions to combat counterfeiting, one of the key priorities for the medical and pharmaceutical sectors. It introduces measures to strengthen the security of the prescription medicines supply chain. This happens via mandatory coding of a serial number on each pack, in the form of a unique, individual and legible number, using a 2D Data Matrix code. Together with anti-tampering devices, this allows medicines to be verified before they are dispensed to patients.
This directive, which requires the marking of primary, secondary and tertiary packaging, affects pharmaceutical manufacturers, importers, third party packers and wholesale distributors of medicines within the EU, as well as manufacturers of active pharmaceutical ingredients (APIs) supplying EU companies.
Global coding, marking and traceability solutions for the pharmaceutical industry to reduce medicine fraud
In order to comply with the FMD EU directive, companies in the medical and pharmaceutical sectors may have questions such as:
- Can labelling, ink coding and laser marking be integrated into the same production line?
- Can the coding and marking of tablets, blister packs, labels, cartons, boxes and pallets be handled in an agile and controlled manner?
- Can complete services be provided, including machinery, software, maintenance and after-sales?
- Can traceability be guaranteed and everything be managed by software that centralises the coding and marking process?
The answer to all these questions is; yes, thanks to SERIAL FARMA. This is Macsa id’s global solution to comply with the mandatory regulations on the serialisation of medicinal products contained in the FMD EU directive.
An end-to-end solution for FMD
SERIAL FARMA is a comprehensive solution that allows companies to adapt to the FMD EU directive and consists of the following components:
- Serialisation Project: consulting and advice on the choice of systems and equipment.
- Coding and marking solutions: Macsa id has a wide range of technology for printing and coding on multiple substrates in the pharmaceutical and medical sector. This includes laser, large character high resolution (LCP), thermal inkjet (TIJ) and continuous inkjet (CIJ) equipment, as well as labelling machines.
- Software Solutions: Macsa id has created pioneering software that integrates marking equipment, Data Matrix code reading and alphanumeric digit control to meet the requirements of the Falsified Medicines Directive (FMD). This software manages the ERP system, the manufacturing orders for unit marking equipment, code readers and viewing cameras, as well as checking the marking and recording information into the database. This complies with the requirements of the European FMD and the US regulation 21 CFR Part 11 of food and drug administration.
Printing and serialisation solutions in the supply chain to reduce medicine fraud
Blister: The ideal equipment for coding blister packs are laser coders (devices) and large high-resolution ink markers. The marking is done directly on the film before the blister is formed. Both technologies allow marking on production lines with high production rates.
Laser technology is characterised by the fact that it is environmentally friendly and does not use consumables. It is legible and permanent, as well as being very flexible in adapting to the specific needs of customers in the pharmaceutical sector. It can mark without loss of quality on a wide range of surfaces: metals, laminates, plastics, paper and cardboard.
High resolution ink technology (idTIJ) and large character ink technology (idJET) enable colour printing at high speeds. These are fully digital, non-contact printing technology that is ideal for printing even the smallest codes.
Case: Each individual case must be marked with codes that ensure unique, global product classification, in the form of a serial number optionally combined with a Tamper Evident label to ensure that the case has not been tampered with. This serialisation ensures transparency of the product origin up to the retail point of sale.
For case coding, Macsa id offers laser devices or small high-resolution ink markers from the TiJ series. For the Tamper Evident sealing system, Macsa id offers MLA label applicators.
This equipment makes it possible to achieve the high production rates required by pharmaceutical production lines, which can reach up to 400 products per minute. Macsa id also supplies equipment for the verification and expulsion of non-compliant products, guaranteeing the quality of the coding and traceability processes for all medicines.
Do you want more information about Macsa id’s solutions to reduce pharmaceutical fraud?
Box: This aggregation level contains previously serialised cases. This level of coding allows serial numbers of the cases it contains to be consolidated into a new, independent unique serial number for the set.
For this operation, Macsa id offers printing and label application equipment from the idBlocks series and high-resolution large DoD equipment.
The print&apply technology allows the printing and application of labels in real time. idBlocks equipment offers a wide range of label applicators to meet the highest demands and needs of the market.
Thanks to the design of the applicator system, it is possible to place labels in any position, at different distances, which adapt to the surface of the product.
On the other hand, DoD technology offers great performance and is designed to work in the harshest environments, adapting easily to the pharmaceutical sector where the printing material is absorbent.
Pallet: This final level of aggregation contains several levels of previously serialised packaging. Pallet labelling allows the consolidation of the serial numbers of the packaging it contains into a single SSCC pallet number plate.
For pallet labelling, Macsa id offers printing and application equipment from the idBlocks series. This pallet labeller, in accordance with GS1 standards, has the capacity to print and apply A5 labels on the two adjacent sides of a pallet. Firstly, to the front, and in a second stop, the rear side, without having to rotate the pallet.
The external structure of the machine has been redesigned to make it more ergonomic and, in its servo-electric version, it can label more than 180 pallets per hour.
Supply chain software solutions to reduce medicine fraud
Macsa id has standardised solutions and a technical team to develop projects that integrate our customers’ information systems with the coding and labelling process in the supply chain. There are also solutions for the automated management of product traceability at all stages of production, adapting to the needs and requirements of customers.
In the specific case of SERIAL FARMA, it is a global solution that allows companies in the medical and pharmaceutical sectors to adapt to the FMD and consists of the following phases:
- Consulting and advice on the choice of systems and equipment
- Control and management of equipment:
- Marking equipment
- 2D code reading and print quality control equipment
- OCR/OCV display equipment to validate readable alphanumeric digits
- PLC line communications
- Database management for FMD compliance
Do you want more information about SERIAL FARMA?
SERIAL FARMA’s main functions
The main functions of the global solution created by Macsa id to comply with the requirements set out in the FMD EU Directive on the serialisation of medicinal products are the following:
- Management of packaging orders: Start, finish, quantities to be produced, quantities produced, lines, etc.
- Serialisation on multiple lines: A single system centralises the serialisation information and allows simultaneous management of all the grouped lines in the plant and devices marking on each line.
- Serial number management and/or generation: The system allows users to receive serial numbers via XML or to generate the serial number based on the information entered manually on the operator’s screen.
- Encoding in different formats: 6 different formats have been considered: EPC Global, SSCC-64, SSCC-96, SGTIN-64, SGTIN-96, GS1 (for printed codes), UPC 12….
- Aggregation:
- The system allows for modelling and communication with each of the markers/printers.
- Each line marker handled by Macsa id will identify the registration of the components and registration/identification of the resulting product.
- The system allows multiple levels of aggregation (of its components and sub-components and also higher aggregation sets to the pallet).
- Reprocessing management: You can manually or automatically report backlogs via the interface. This data is taken into account in the disaggregation of information.
- User management 21 CFR Part 11:
- The system manages and maintains the security and permissions of users and groups.
- Association of permissions for screens and functionalities associated with different user levels.
- Traceability of actions performed by users.
- Security levels for users.
- Records of actions carried out in the system.
- Process audit: registration and consultation of modifications in the database tables.
- Reporting and monitoring:
- Historical consultation screen: batches, productions, etc.
- Aggregation query screen
- Data storage/registration in SQL database systems: The installation wizard is used in the setup of application packaging and database tables.
- Integration with SAP and other ERPs: Data exchange via XML according to SAP and other standard formats.
Macsa id, the experience of a market leader in coding
Macsa id, the world’s leading manufacturer of coders and equipment for the marking industry, provides customers with the technology to meet their product identification and traceability needs.
This offer includes hardware, projects, software, consumables, spare parts and technical services. In addition, for more than 15 years, Macsa id has been designing customised solutions and software management applications for marking and coding processes. SERIAL FARMA was born precisely as a result of this experience, becoming the world’s first solution for companies in the pharmaceutical sector that want to adapt their production line to FMD and other international standards.