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Pharmaceutical Manufacturing and Packing Sourcer

New Order

Ultimately the directive will mean improved patient safety and the opportunity for competitive advantage. Consumer protection and an everincreasing concern for health and safety have become a central issue in the pharmaceutical supply chain due to the need to track medicines moving from manufacturer to dispensing pharmacy. In this context, the falsification of medicine refers to any medical product with a fake counterfeit representation of any of the following criteria:
  • Identity – including packaging, labelling, name or composition in respect to any of its components
  • Source – including the manufacturer, country of manufacturing, country of origin or marketing authorisation holder
  • History – including all records and documents relating to distribution channels
For manufacturers of medicinal products, this means a legal requirement to apply safety features which make it possible for wholesale distributors (or any other authorised supplier), to uniquely identify and verify the authenticity of individual packs, ensuring that external packaging has not been subject to tampering. In addition to finished medicines, the Directive will also extend to active substances within two years.

This development is significant in the light of current market trends, which show manufacturers looking to outsource their logistics operations to specialist third party logistics providers (3PLs) or, where feasible, introduce direct to pharmacy (DTP) supply practices in an effort to reduce costs. In view of this, one can understand the motivation of the European Federation of Pharmaceutical Industries and Associations (EFPIA) for improving the falsified medicines legislation and protect the consumer.

Systems in Place

A variety of solutions are already in existence to enable manufacturers to achieve compliance with the new Falsified Medicines Directive in a cost-effective manner. For instance, high-speed print and apply marking systems are available that allow secure identification and serialisation of the secondary packaging of medicines and medical goods at the production line. These work by allocating and applying a unique datamatrix code that includes information such as expiry date, lot number, product number and a serialisation code.When combined, this data helps combat counterfeiting or theft and facilitates fast resolution of claims/recalls because products can be checked for authenticity and tracked throughout their life cycle. In addition, the improved supply chain visibility and business intelligence reduces costs and enhances decision making ability.

Several international manufacturers have already implemented a serialised print and applied labelling systems that work across multiple production lines ahead of February’s Directive being passed. Their solution sequentially labels products, introduces a tamper-evident seal and completes the Datamatrix marking, coding and verification procedures as required by CIP 13. In this instance, care was taken to ensure the systems installed were designed to avoid adversely affecting production speeds and will be compatible with future serialisation requirements.

Capturing Competitive Advantage

In addition to compliance with new smart legislation, other currently voluntary improvements to data capture and traceability made by pharmaceutical manufacturers can deliver considerable competitive gains.This is achieved through greater differentiation, reduced costs, better product quality and increased long-term profitability. In turn, these benefits translate into improved reputation and the ‘preferential brand status’ that this automatically affords. Research by the reputation specialist Professor Charles Fombrun has shown that companies with a superior reputation benefit from the ability to charge premium prices, can obtain financial investment more easily, attract the best talent as employees, and recover more quickly from a crisis.

There is also an opportunity here for the pharma industry to learn from the ultra competitive food and FMCG sectors to achieve faster, more accurate order preparation with advanced stock picking strategies, greater shipment accuracy, improved product quality, as well as allround superior safety through better cool chain management.The increased visibility that such systems deliver will also improve customer intimacy levels by allowing a greater understanding of consumption patterns.

Enhanced Order Preparation

The application of proven stock picking strategies can assist with this goal.Manufacturers need to supply pharmacies with the right order in a timely manner, often many times a day and at short notice. Pharmaceutical wholesalers/distributors and logistics companies can very quickly optimise order preparation processes by applying the voice-directed picking techniques adopted by food retailers in particular. ‘Pick to voice’ as it is also known, has been proven to cut costs and improve operational efficiency by up to 40 per cent, depending on existing processes. The results are faster, more flexible stock picking, fewer mistakes, lower labour and training costs, as well as workforces that can be managed flexibly around peak times. It is also possible to combine voice picking with either manual or automated scanning systems to eliminate the requirement for any pre-despatch verification.

The benefits of this to a business have been proven first hand at CERP, a French/Belgian pharmaceutical distributor and one of the first companies to use voice picking. Their system, which also verifies Datamatrix product codes, has allowed CERP to adopt a ‘just in time’ operational mode for deliveries to pharmacies. Competition in the pharmaceutical distribution sector is intense and great importance is placed on the delivery speed. For instance, a pharmacist placing an order in the morning expects to receive their stock in the same day or overnight in the case of afternoon orders. The system supports hundreds of operators across the country and uses the MCL-Voice recognition engine with Motorola MC3190 terminals.

In addition to reducing labour costs and the time taken for orders to be shipped out to pharmacies, the voice picking system also helps CERP comply with the CIP 13 traceability legislation introduced for manufacturers supplying medicines within France. As the warehouse operator picks items within each pharmacy order in response to spoken instructions from the voice picking system, each product selected is also individually scanned using a wearable ring scanner to capture the datamatrix code.This extra verification step ensures batch references and expiry dates are recorded for each item that is to be delivered, which is useful in the event of a product recall.

Full Shipment Accuracy and Supply Chain Visibility

There are other opportunities for pharmaceutical manufacturers and distributors to benefit from data capture and the increased visibility it brings. Next generation automatic shipment verification solutions use image-based technology to ensure that the right medicines are sent to the right pharmacy or hospital and the effectiveness of these systems is proven.They have already been employed by food and beverage manufacturers supplying major supermarkets in order to avoid penalties imposed for errors, because they can ensure 100 per cent accuracy of shipped pallets.Using this technique it becomes straightforward to inspect items when preparing boxes or crates on the production line, manage returns from pharmacies and create a log of all unique identifiers placed on crates and cartons in order to maintain a record of products shipped. For manufacturers adopting the DTP distribution model, a technology such as this will help to control labour costs and minimise errors.

Improved Cool Chain Management Ensures Medicine Quality

RFID technology offers significant advantages for cool chain management and ensures that certain medicines such as vaccines and antibiotics are stored at a constant temperature along the supply chain. In a temperaturecontrolled environment, the entire operation is only as strong as its weakest link, with every negative impact having a cumulative effect on product quality, including point of sale. Using special RFID tags, it is possible for pharmaceutical companies to monitor temperature levels, ensure that information about any inappropriate events are being escalated, and to maintain optimal product quality from the moment medicines are produced to the time they are dispensed to patients.

While this review of technologies and existing implementations proves the capability to do this exists already, implementing the Directive properly will also require the co-operation of all stakeholders. Indeed, the detailed notes emphasise the collective responsibility of all stakeholders within the pharmaceutical supply chain to inform the competent authority if any medicinal products are suspected of being falsified, irrespective of whether those products were distributed by legal or illegal means. In practice,we believe it will be necessary to create a pan- European system with the support of manufacturers to assign and store unique numbers for all products. Having data in a central repository such as this will mean product serial numbers can be checked against the items that have been previously dispensed to prevent the possibility of counterfeiting, but this will require a significant increase in data volumes stored between partners. Incoming legislation to increase patient safety clearly creates a challenge for the entire industry, but rather than simply representing additional unnecessary ‘red tape’, this offers a number of real business benefits.

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Pascal Durdu is currently Director of Business Development and Innovation within Zetes, based in Brussels, Belgium. He is responsible for creating and deploying new solutions covering requirements in traceability in the supply chain for several industries, including pharma and healthcare. Prior to Zetes, Pascal worked in various innovation, logistics and management roles at Procter & Gamble, Orange, KPN, Belgacom, Centrality and Sirf technology. He has been involved in a range of projects, and had international work experience in Belgium, UK, Germany, Netherlands and Cameroon. Pascal holds a degree in Engineering from UCL in Louvain-la-Neuve, Belgium, and a Master’s in Industrial Management from KUL in Leuven, Belgium. Email:
Pascal Durdu
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