White Paper. Serialisation of Pharmaceuticals A Key to Success for the Pharma Industry PCE. Trust METTLER TOLEDO to show you the way

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1 White Paper PCE Pharma Vision Inspection Trust METTLER TOLEDO to show you the way A Key to Success for the Pharma Industry

2 Contents 1 Trust is good Cutting-edge technology is better! 2 Are you prepared for Track & Trace? 3 Consistency, transparency and tracking 4 The challenge Handling large volumes of data 5 Different countries, different needs 6 Components of an ideal solution Consistency pays off 7 Your supply partner needs to be an international expert 8 Practical advice: Suppliers of complete solutions offer many advantages and benefits 9 Fully equipped A sustainable solution for future success No part of this publication may be reproduced or distributed for any purpose, regardless of the technique or method used to do this, without explicit written permission from Mettler-Toledo Garvens GmbH. All rights reserved. Subject to technical changes. Mettler-Toledo Garvens GmbH makes no warranty for the accuracy or applicability of the information contained, and is therefore explicitly not responsible for damage to property and/or injuries to persons resulting directly or indirectly from the use of this information. 2

3 1 Trust is good Cutting-edge technology is better! Where health is concerned, trust is central to the healing process. In addition to the medical knowledge of the physicians who treat us, and confidence in our own body's defences, above all we trust in the efficacy of drugs. After all, science is developing more and more effective drugs which critically advance recovery. But trust in pharmaceutical manufacturers is being shaken more and more by counterfeit products. Such counterfeits are drugs and pharmaceutical products which may not contain the effective ingredients, and may have adverse effects, in the worst case resulting in fatality. WHO, the World Health Organisation (2010), estimates that 10% of the drugs sold worldwide are counterfeit products. It has also been suggested that 50% of the drugs ordered via the internet are counterfeits. Pharmaceutical counterfeit products are already a worldwide problem! International pharmaceutical markets are widely penetrated by counterfeit products, which are very profitable for the criminals involved. Consequently, many of the key health organisations and authorities are in agreement about the need to take decisive measures against these activities (Source: IMPACT, International Medical Products Anti-Counterfeiting Taskforce, updated May 2008). But this is not straightforward as pharmaceutical products are produced internationally. Financial considerations encourage manufacturers to act across national and continental boundaries. For example, a drug may pass though Asia or Eastern Europe en route to its destination. Production, packaging, repacking and shipment are part of a global value-added chain which does not lend itself directly to consistent controls. Serialisation, the unique testing and monitoring (Track & Trace) of medications throughout all manufacturing steps, is becoming the decisive activity for achieving quality, safety and trust. The startling increase in product counterfeiting calls for security in the supply chain within a global market. For this reason, many countries have started to implement new laws in order to eliminate weak points in the supply chain. On a European level, decisive steps have been taken to that effect. To prevent counterfeit medicines from entering the legal distribution chain, in 2011 the European Parliament adopted a corresponding EU Directive on Falsified Medicinal Products, Directive 2011/62/EU. This requires all EU member states to have established a system that will protect their citizens from counterfeit medicinal products by The EU Directive on Falsified Medicinal Products contains a variety of initiatives for protecting both the supply chain and patients, and also requires complex identification and authenticity markers to be included on the outer packaging of medicinal products. The primary focus of these initiatives is the inclusion of special safety markers on medication, such as 2D barcodes. Using codes like these, the chemist is able to check at the point of issue whether medicine packages have come from legitimate sources. The requirement for medicines to be clearly identifiable and traceable is by no means restricted to Europe: a wide range of institutions, such as the US Food and Drug Administration (FDA) are calling for the same. 3

4 2 Are you ready for Track & Trace? Waiting is not an option. The laws and regulations on serialisation will affect the entire pharmaceutical industry. Even today, manufacturers can and should work on the basis that, by 2017, it is extremely likely that all medicinal products requiring verification will have to be printed with coded serial numbers marks the end of the transitional period in which the EU Directive on Falsified Medicinal Products will need to have been implemented in all EU member states. By this time, production lines will have had to be modernised to incorporate elaborate technical coding and image recognition systems capable of functioning reliably even at high production speeds. EU Directive on Falsified Medicinal Products It is assumed that, from 2015 at the latest, system suppliers will experience a huge boom, resulting in corresponding increases to waiting times and supply shortages (German Association of Pharmaceutical Wholesalers [PHAGRO], 2013). This could even result in some medicinal manufacturers not being able to mark their products appropriately by the proposed deadline, leaving them unable to be marketed. Introducing a reliable serialisation system is not only time-consuming, but also demanding on a technical level. The tasks include adapting the IT environment in the production and packaging of the medicines, implementing printing and camera systems, and employee training, to name but a few. Manufacturers have to ensure that product authenticity is guaranteed. This is the only way to stop counterfeiters in their tracks and prevent fatalities arising from counterfeit medication. In addition to the dangers to consumers, the increasing losses seen by pharmaceutical companies as a result of counterfeiting also offer strong grounds for a shift in mentality. Serialisation systems not only ensure that the integrity of the brand name is protected, they also boost the confidence of patients and pharmacy customers. The discussion surrounding serialisation solutions is increasingly gaining momentum. In light of the present legal situation, it is strongly recommended that pharmaceutical companies take the initiative and start communicating their requirements in terms of product line serialisation to reliable partners. With this in mind, investments in printing and camera systems, along with technical solutions for producing randomised serial numbers should be regarded as both necessary and long-term measures! 4

5 Note: The Garvens Glossary defines and explains technical terms in the field of serialisation. It also refers to existing global norms and standards. As a source of reference material, the explanations cover general terms, individual coding forms and relevant organisations. For further information see: 5

6 3 Consistency, transparency and tracking The value-added chains of the pharmaceutical industry have an international perspective. Manufacturers operate production sites in various countries all over the world. Consequently the requirements for consistent control of pharmaceutical products are confounded by variations in national laws and regulations, as well as differences in technological equipment. The goal of consistent traceability of pharmaceutical products needs solutions for serialisation which comply with all the national requirements, in order to ensure a consistent product pedigree, e.g. from manufacturer, to wholesaler, to pharmacy. Only an integrated serialisation program can ensure consistent control of the product, from manufacture through to delivery to the customer. In order to address the problem of pharmaceutical counterfeits it is not sufficient simply to mark packages with encoded safety characteristics. Transparent data management, comprising all production steps and distribution channels, needs to be the basis for controlling and tracing pharmaceutical products throughout the supply chain. Transparency in the pharmaceutical packaging process In some instances, a single nation's requirements can have a strong impact on production. For instance, in international companies pharmaceuticals destined for different countries are manufactured on the same production line. The precise allocation of the appropriate information package requires considerable knowledge. Just allocating the serial number can be a challenge. 6

7 Increasing numbers of countries worldwide are saying that legal regulations are the only way forward for an effective fight against counterfeit products and falsifications of single pharmaceutical packages. Manufacturers face the challenge of differences between national requirements, deadlines and control mechanisms. There is also a need for future-oriented solutions for technology and data management in order to accommodate frequent modifications and amendments to existing national regulations, which complicate preparation of a standardised serialisation solution. Regardless of which concept is implemented, what is sure is that the production of pharmaceuticals is no longer restricted to simply manufacturing medicines. Now, even the way in which data is managed and passed on to pharmaceutical customers and consumers in a secure, controlled environment is of paramount importance. The diversity of laws and standards in the global pharmaceutical market requires different serialisation information for different countries. This information, which has to be observed by the manufacturer and its equipment suppliers, is likely to include much of the following: Consistent evidence of origin throughout the supply chain, from the manufacturer through to those who hand the drug to the patiens Detailed information for each company (e. g. name, address, date of production, batch number) certifying the prescription drugs Name of the prescription drug, its quantity, form, strength and dosage Date of each transaction in the distribution chain Sales invoice number(s) of each transaction Number of packages in each transaction Lot/ batch numbers, and date of expiry Complete shipping information Declaration of correctness and truth of information at each stage 7

8 4 The challenge Handling large volumes of data Pharmaceutical companies would be well advised to tackle future requirements now. When serialisation programs become mandatory, high performance fail-safe systems will have to be in place in order to process and store the mountains of data. As is the rule in this industrial sector, all the systems employed will have to be validated according to Good Manufacturing Practice or FDA Directives. The minimum requirements for a comprehensive serialisation program must follow the prevailing requirements which can differ from country to country. The following headings provide an overview of the present framework of requirements: Certification: demonstration of the path from patient back to the original manufacturer of the prescription drug Validation: the serialisation data must be checked to confirm that it matches that on the received product Complete control: companies must provide the evidence that all stored pharmaceuticals with potential for fraud have been serialised Completeness: serialisation information must be consolidated on transfer of the product Documentation: must be traceable, complete and correct Automated electronic solutions are a prerequisite in order to meet the country-specific requirements. Only such solutions can maintain a data management system which operates safely and reliably throughout all production stages. Furthermore, manufacturers may be asked to offer modular and scalable systems for integration in various production lines, in order to address any variation between the requirements of individual countries. This goal can only be achieved by equipment suppliers with a global presence. Note: For more information on marking, verification and product safety, please see our white paper entitled: "Aggregation Integrated solutions for the traceability of products" For futher information see: 8

9 Features of any future system would include: The ability to handle high volumes of data: depending on the length of the supply chain, a considerable volume of serialisation data may need to be processed Storage of informationen: each partner in the supply chain must keep documentation of all products, including the certificate of origin, for several years Reliability: the serialisation information must be captured and stored before a product is dispatched Certification: each organisation from the manufacturer onwards must be able to authenticate its part in the supply chain, maintain a record of this authentification, and certify that the shipments have complete and accurate documentation Reference: An increase in efficiency of modern production lines is achieved, above all, by a higher throughput rate. As a consequence, the time available in future programs to serialise pharmaceutical packages will be further reduced. Printing, product hierarchy (e.g. a single folding box, a bundle or a pallet) and storage of data will have to be completed under the pressure of time. The same applies to data processing, from the device reading the code up to the company-wide data processing systems. But at all levels, safety has to be ensured a technological challenge to be faced by both the pharmaceutical industry and the supplier of serialisation solutions. Many companies use the OEE process Overall Equipment Effectiveness as an indication of their efficiency. On the basis of "Availability, Performance and Quality", a factor is calculated which clearly provides information about performance on the production line. The serialisation solution within the company can be measured in this way. A score over 85% represents world class performance. Note: For more information on how overall equipment effectiveness is calculated, please see our white paper entitled: "A Guide to OEE". For further information see: 9

10 5 Different countries, different needs Evolving Rules and Regulations Require Future-Oriented Solutions. The production of pharmaceuticals and drugs follows the rules of international value-added chains and their complex structures. Prescription drugs are distributed to every corner of the world. To enable this, a highly complex supply chain is essential from the manufacturer through to the end customer. Drugs are produced, distributed, repacked and sold on by a sequence of organisations before the goods finally reach the patient. In addition to the challenge of international logistics, the different regulations of the countries concerned require serialisation solutions to be sophisticated. Not even in the longer term can we expect homogeneous standards for international trade in pharmaceuticals, and the continuing evolution of country-specific standards presents a challenge for serialisation. As a simple example, differences between countries can be illustrated by the way Expiry Date is expressed. In Germany, the date is expressed in the order "Day/Month/Year", whereas in the USA it is "Year/Month/Day". Prevailing standards in Europe and in other continents differ considerably and may undergo modification during implementation of serialisation. Thus it will be essential to ensure any anomalies introduced by the legislative bodies are addressed using lessons learned from practical experience. It is vital for communication between pharmaceutical companies and government agencies to run smoothly. This ensures that information concerning new laws or amendments to existing ones can be passed on promptly. The services of serialisation solution providers and production line suppliers are in demand in this area too. They should follow suit and develop a solution that is already flexible enough to accommodate future changes. 10

11 Nevertheless, globally, there are numerous initiatives which are working towards the common aim of serialisation, but different countries have their own approach to realising it. For instance: Germany Product number, serial number, batch and expiry date with datamatrix code Turkey GTIN, serial number, LOT and EXP date marked on the product Brasil GS1 datamatrix code (13 digits ANVISA product code, serial number, LOT and EXP date EFPIA Concept harmonisation of pharmaceutical products codification throughout Europe via serialised datamatrix codes, with additional information, e.g. EXP date, also to be printed on the product E-Pedigree Law, California electronic pedigree to track and trace prescription drugs through the entire supply chain Practical experience shows that changes in legislation, in different countries, will continue to require adaptation of production lines and basic software in order to comply with serialisation requirements. Such changes will rapidly put pharmaceutical companies in a difficult position. The question is: will the equipment that you buy today be able to comply with future serialisation requirements? We are looking for a global solution which can be implemented locally. Each supplier of serialisation solutions faces this challenge. This will give a clear advantage to suppliers with an international reach. Video: Mettler Toledo Garvens serialisation solution in use Note: Some pharmaceutical companies are already equipped with optimum serialisation solutions. Read our case study on the use of the Mettler Toledo Garvens serialisation solution "XS2 MV" at Medac GmbH, a German company that produces special clinical preparations. For further information see: 11

12 6 Components of an ideal solution Consistency pays off A consistent serialisation solution aims at reaching the highest transparency possible in a pharmaceutical packaging process by tracing the single package back from the patient. Can this ideal be achieved? The first step is to generate individual serial numbers for each packaging unit. In order to trace the product back during the production and packaging process, this code will be applied to the folded boxes, vials or bottles in plain writing, or as a 1D or 2D barcode (datamatrix). Marking and recording of the single unit (folded box, vial, etc.): the code is marked on the single units with an ink jet or laser marker. A multi-functional Smart-Camera immediately examines the package to verify that the marking is legible and correct. All non-compliant units are rejected directly and only good units will continue to pass through the packaging process. The status of each unit will be recorded in a traceable way. The data generated during the marking and control process will be stored directly in the database and are available for further processing. Marking and recording of aggregations (bundles, shipping cases, pallets, etc.): recording the single units is followed by documentation of the parent/child relationship as the basis of the complex aggregation process. This requires corresponding modules for marking of bundles, covering boxes and pallets by using intelligent Smart- Cameras or high resolution and PC-based megapixel cameras. The recorded units of the corresponding collecting units (e.g. shipping box) are logically assigned to ensure complete traceability. This process can comprise several packaging steps, depending on the design of the production line. Safe storage of production data is the key: efficient and cost-oriented serialisation solutions ensure a possible connection of several lines (even at different production sites) to a central database. A central server transmits the data from all devices to, for instance, the standard SQL database and thus allows archiving to be achieved safely. Later, this data pool will form the basis for creating the corresponding reports (records/protocols). This presents an easy way to fulfil regulatory and internal requirements. Integration of different solutions into the customers' existing IT structures is facilitated by industrial standards like Java and SQL. Connection to existing backend systems (e.g. SAP, ERP or SAP All in One) is possible via standardised XML interfaces, provided that the supplier of the solution can offer appropriate guidance. 12

13 The requirements for an ideal serialisation solution are set at a high level. Only an efficient data management system allows consistent tracking and verification of drugs over the whole production and supplychain. This applies for all systems and for all production and distribution processes both for ERP systems and for systems of supply chain management. Furthermore, the different national regulations mentioned above also have to be satisfied, like adaptation to different technical designs of production lines. The advantages of a cutting-edge serialisation solution for the pharmaceutical production industry are clear: Increase of equipment efficiency by faster adaptation to international requirements Anticipation of potential future global regulations in case of a comprehensive solution Reduction of cost by: Prevention of rejections, downtime or recalls by increased transparency Reduction of staff cost through improved software Brand protection and confidence-building by a consistent control system which, through the verified traceability of the products, provides protection against counterfeits. 13

14 7 Your supply partner needs to be an international expert You are likely to require a supply partner which is technologically capable, and also experienced in developing and implementing solutions internationally. New systems must be validated, ready for operation, and fail-safe. This includes integration of new components into existing production lines. In order to overcome the well known interface problem.a solution needs a network of technicians who will be available at short notice when problems arise at a production site. Maintenance has to be available at any location worldwide. The supply partner must be a company which can provide customer-orientated advice. This should automatically include a worldwide monitoring of regulatory changes and amendments, and on-demand transfer of valuable information directly to the customer. They should provide active support of the customer with regard to cost management and minimisation of risks. Clearly, the best basis is a long-term business relationship, especially in the case of international pharmaceutical manufacturers. After all, a serialisation project may last over a period of one or two years, involving several sites.. Given the complex requirements in terms of production line infrastructure, pharmaceutical companies should decide upon a suitable partner at an early stage in the process. 14

15 When selecting a supplier, the following factors should be an absolute priority: Level of information: Does your supply partner know and monitor the current regulatory requirements in various countries? This could be decisive for ensuring the required functionality of the solution. Moreover it will pay you to have a valued partner for long-term strategic initiatives. Know-how regarding integration: Is your supply partner able to supply solutions for established components and technologies already present in your production line? This would considerably reduce integration costs and timescale. Competence: Is there any proof that your partner will be able to furnish the required performance? Even in the long-run? Does the possibility of an international roll-out exist? Stability of resources: Does the partner have the financial stability and resources to meet short-term requirements and to deliver an economical service in the long-term? Efficiency of service: Does the partner offer a global service with support strategically located for rapid response when needed on site? Capabilities: Are the solutions offered by the supply partner flexible enough to integrate with existing software and hardware, including the possibility of easy integration with new technologies and evolving requirements? Has the partner already proved that he can successfully carry out projects professionally and without delay? In an international context and in large numbers? Integration of components, software and hardware from other equipment suppliers is among the classic problems faced when implementing a serialisation solution. The new components may satisfy the requirements, but adaptation problems may arise when combining with existing equipment, and this can result in time delays and additional costs. Experience has shown that co-operation with a central supplier, who already works together with other suppliers and has knowledge of combining components, is the most advantageous solution. This especially applies if optical verification, marking and checkweighing are required in a complex serialisation.. Camera system: The camera system receives the serialisation data from the central database, gives this information to the printer and then examines the package marking to verify that the marking is legible and correct, before signalling back to the central database that the serial number has been allocated. Your supplier should be able to integrate the camera software and hardware of your choice to minimise integration issues. Marking: Printing can be done using an ink jet printer or laser marker directly on to the packaging, or by using a labeller. It may be advantageous to use printing solutions of your choice which are already in use on your production line and fulfil your printing requirements. Checkweighing equipment: This can ensure that the contents of each package, as marked and verified, are present and that each package is complete. To keep critical quality control points to a minimum, normally the best location to place your serialisation marking and verifying equipment is directly before the checkweigher. 15

16 8 Practical advice: Suppliers of complete solutions offer many advantages and benefits It is not only legal requirements, but also the continually rising demand for quality and traceability in pharmaceutical and medicinal products that have long since led to a need for modern system solutions in the areas of quality assurance, serialisation and Track & Trace. We strongly advise you to choose a key supplier that has already established successful partnerships with other suppliers and has experience in combining technologies in a complete serialisation system, such as marking, visual verification, checkweighing and tamper evident sealing. Depending on the installation conditions and the layout of the production lines, two different solutions are available. The stand-alone solution with the "Mark + Vision" component (M+V solutions, i.e. solutions with a marking system and verification camera) for retrofitting on a production line. Or, there is also the comprehensive all-in-one combination solution which is made up of different types of technology like a checkweigher component or a tamper evident seal applicator. The advantages of a complete solution such as this include its simple integration into the production line and the knowledge that all the components are sure to work together smoothly. Complete solution suppliers also offer a single point of contact for service and support. The decision to opt for a complete solution supplier offers the following clear advantages One point of contact for all systems concerned A single just-in-time supplier of ordered components, rather than several equipment suppliers Compatibility of components Combined systems are more compact, allowing easier line integration, and have fewer moving parts, thereby reducing maintenance time and cost Reduction of user interfaces minimises operation errors and makes product changeover faster and more efficient, reducing downtime Introducing any new piece of production line equipment can have influences on your Overall Equipment Effectiveness (OEE). To ensure that this is not the case you must be careful to choose equipment suppliers who are competent at processing difficult to handle products at high throughput. Slowing down your production line is not an option. Look for solutions which have line speeds of at least 90 m/min. This will enable you to maintain current throughput levels and give room for future speed increases. Safe and smooth product transfer especially onto the system and precise transportation of the product in front of the printer and vision system are critical in ensuring a good printing quality and best possible marking verification. Imprecise product handling will lead to an increase in rejected products and could lead to backups and jams which will inevitably cause and increase downtime occurrences. Your production line equipment supplier should understand OEE and should be able to supply solutions which will not negatively affect it. Solution for serialisation and tamper evidence: 4-in-1 combination solution for highest process safety: XS2 MV TE The compact and space-saving XS2 MV TE checkweighing and marking system combines ink jet printing and vision verification with highly accurate in-motion weighing and tamper evident sealing to ensure global traceability and assist fraud protection. Process safety is increased thanks to the full enclosure with electric locks preventing access during production. The system is also available as a 3-in-1 combination with checkweighing and marking & vision. Visit us: 16

17 When selecting a suitable equipment supplier for your production line, the priority should be an individual serialisation solution which offers the following performance features: Performance features Stand-alone range through to all-in-one solution (weighing, marking & vision, tamper evident sealing) Optimum production flow Integrated data flow CFR 21 Part 11 conformity Various printing technologies High-quality printing Conformity with current and future legal requirements and international printing standards Flexible printing and tamper evident label positioning High throughput System qualification Advantage for customer Simple and space-saving line integration Exceptional reliability thanks to perfectly coordinated system components Potential for total integration into existing ERP systems for a seamless, automated data flow Total traceability, archiving, audit trails and documentation as proof of validation Inkjet printing, laser marking Reduction of waste and increased productivity Printing of individual number sequences, e.g. for batch numbers and expiration dates, as well as the code standards required for serialisation, e. g. 2D data matrix code Front, rear, top of the packaging (both "either/or" and "in combination") High throughput for weighing, M+V and tamper evident sealing; guaranteed quality and future-proofing for reliable investment protection High-quality, individual validation and qualification documents Optimum product handling Secure and reliable product handling, ensuring the highest-quality printing Examples of serialisation solution suppliers include Mettler-Toledo Garvens GmbH and Pharmacontrol Electronic GmbH, who, as suppliers of individual complete solutions, provide the optimum combination of their system components. Mettler-Toledo Garvens GmbH, for its part, is the world's leading supplier of dynamic checkweighing solutions in the pharmaceutical industry. As a long-standing expert in the field of optoelectronic inline monitoring and image processing systems for the pharmaceutical packaging industry, Pharmacontrol Electronic GmbH is the leading partner for printing and camera systems. Together, both partners can boast many years of experience in the development of production inspection systems for the pharmaceutical industry, and even have one of the largest bases for installed serialisation systems at their disposal. METTLER TOLEDO serialisation solutions support pharmaceutical manufacturers by fulfilling future legal requirements for the serialisation of pharmaceutical products and, in doing so, provide protection for brands and customers. Not only do the solutions cover all steps in the production process, customers also benefit from a comprehensive range thanks to METTLER TOLEDO`s global sales and service network. Solution for serialisation: Stand-alone solution: XMV Thanks to its additional Track & Trace functions, the XMV system with integrated inkjet printer and verification camera enhances existing or new production lines. In no time at all, it can be integrated into any application in which the production process has to conform with pharmaceutical requirements such as 21 CFR Part 11, total traceability, audit trails and documents that support validation. Visit us: 17

18 9 Fully equipped A sustainable solution for future success The EU Directive on Falsified Medicinal Products requires existing production lines to be retrofitted for pharmaceutical products whilst also adhering to the transition deadline, which is likely to be the first quarter of Manufacturers are advised to invest in a future-oriented infrastructure for serialisation well in advance, and to prepare for 2017 as quickly as possible in order to ensure the safety of their customers and the marketability of their products. In addition, international standards further afield than Europe have to be strictly observed where pharmaceutical companies operate in a global export network. But there are also other reasons which support this type of investment. The increasing speed of production processes requires systems which are able to control and document the quality and authenticity of products, and currently that is only feasible with sophisticated systems and equipment. This is the only way for the pharmaceutical industry to ensure that the right quantity of the right product will be delivered at the right time to the right location. If this is not achieved then costs and other impacts will increase significantly. The administrative chain itself may be a key element in enhancing service and customer satisfaction. It is possible that public demand for consistent and comprehensive track & trace systems will increase, consistent with a rising number of critical consumers and the wishes of patients to be able to determine the origin of a drug and confirm its legitimacy. For the pharmaceutical industry, traceability of the product pedigree, even for the end customer, can be a challenge. For this reason, investments should not only be in the light of legal regulations, but also form a strategic investment for the future. Close co-operation between a manufacturer and an experienced supply partner is a sound basis for moving forward. 18

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20 Further information from Mettler-Toledo Garvens GmbH Telephone Telefax Further information from Pharmacontrol Electronic GmbH Telephone Telefax Diverse sources of information: World Health Organisation (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT) United States Food and Drug Administration (FDA) National Institute of Standards and Technology European Federation of Pharmaceutical Industries and Associatons (EFPIA) Global Standards One (GS1) SecurPharm For more information Mettler-Toledo Garvens GmbH Kampstrasse Giesen, Germany Telephone +49 (0) Fax +49 (0) garvens@mt.com Subject to technical modifications Mettler-Toledo Garvens GmbH Pharmacontrol Electronic GmbH A member of the METTLER TOLEDO group Gernsheimer Straße Zwingenberg, Germany Telephone +49 (0) Fax +49 (0) pce@mt.com Subject to technical modifications Pharmacontrol Electronic GmbH 20