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Pharmaceutical Manufacturing and Packing Sourcer

Securing Patient Safety

RFID technology can deliver operational efficiency to the pharma industry and underpin consumer confidence

Constantly changing legislative, economic and competitive pressures on pharmaceutical manufacturers mean businesses are confronting two key market drivers. One is the need to improve production and process efficiencies to reduce costs and encourage competitive advantages; the other involves dealing with the industry effects of market globalisation.Proven technology developments such as radio-frequency identification (RFID) and the growth of unique product identification concepts through the complementary approaches of serialisation and ePedigree, can offer real solutions for an industry that is seeking answers to satisfy these twin challenges.

Businesses are needing to increase operational efficiencies and create manufacturing flexibility, with a keen eye on costs, to ensure they can deliver quick, problem-free production changeovers to respond to fluctuating market influences and trends.They also need to protect themselves against the increasing levels of government and legislator scrutiny that is heavily focused on patient and product safety in the global marketplace.This is in the context of a continuing worldwide trade in counterfeit drugs that currently accounts for five per cent of all drugs sold (1).

Radio Frequency Identification

RFID is in many ways not a new technology. It employs ‘smart tags’ to track, trace and identify many types of item and has been used in some form for a number of decades, predominately in the automotive and electronic sectors. However, over the past 10 to 15 years a renewed interest in the advantages of calling up complete product profiles has had great appeal for many other manufacturing sectors, with some parts of the pharmaceutical manufacturing industry seeing its obvious potential.

In essence, RFID allows a physical entity, such as a component or a container, to be automatically identified as it moves along the supply chain.The technology consists of three vital elements. Firstly, a tag (chip plus antenna) is attached to the physical entity in question. Secondly, a reader is used which can ‘read and write’ data to and from the associated tag. The third element is a system’s ability to communicate with a ‘real-time’ communications platform. One of the flexible characteristics offered by RFID is that information on the tags is read by sensors which, unlike barcode equivalents, can communicate with many tags at the same time and do not need the tags to be in their direct ‘line of sight’.This enables physical items with tags attached to be identified automatically, removing manual intervention, improving processing accuracy and speeding up overall operation. It can act like a mobile database – as opposed to a barcoding solution which has to link back to a centralised database.

RFID tags can be used in a number of formats, for example in repeat manufacturing operations, as well as in disposable packaging formats with information available over the lifetime of the package. Such tags are becoming more prevalent and are increasingly cost-effective as they offer the opportunity to track and trace items over the entire end-to-end supply chain.

Such technology enables the tracking of goods from their point of origin to help create a proven and high quality level of supply chain transparency.With RFID, each individual product possesses an electronic ‘pedigree’ containing all the relevant information on the product, such as the raw materials used, production data, shipping dates, storage conditions and times, and the sale and application of the product. This essential information can be used to improve many operational elements for pharma companies, ranging from product availability at the point of sale to stock management, lead times, investment planning and, ultimately, customer satisfaction.

It can also play a pivotal role in enhancing productivity and product security which are important factors for pharmaceutical companies. In the healthcare sector, such information can be utilised as a key tool for product authentication – which is a weapon to combat grey market, theft and drug counterfeiting activity.

Serialisation

The drive to increase the standards of product security for pharma companies has lead to the growth and adoption of the concept of serialisation as the next stage, building upon the benefits clearly seen and derived from RFID technology. As globalisation across the pharmaceutical industry increases, so too does the complexity of its supply chain, posing new challenges and, potentially, bringing new levels of vulnerability to companies that develop, manufacture, distribute and dispense drugs. Because of notorious episodes concerning tainted or counterfeit products, governments have led the way in making supply chain security a top priority, and as a means of enacting and implementing traceability, politicians and legislators have encouraged moves behind the introduction of item-level serialisation.

Serialisation is a process of identifying an object with a unique serial number which can be exchanged universally. Within the pharmaceutical industry it can be applied to each item, case and pallet of a drug to authenticate the individual product and enable tracking and tracing (and building a pedigree) within the supply chains of manufacturers, distributors and wholesalers.

The requirements for serialisation are growing in both the US and Europe, and have included the FDA developing a standardised numerical identifier in the US. Nearer to home, the European Federation of Pharmaceutical Industries and Associations (EFPIA) – through its 31 national pharmaceutical industry associations and 44 leading pharmaceutical companies – is adopting a pilot coding solution for Europe (2).This is to perform product authentication at the point of dispensing with a serialised datamatrix code on secondary packaging of all products sold in Europe. EFPIA’s clear objective is to improve patient safety at a European-wide level. It will be interesting to witness how the legislative enforcement evolves as the global market implications are tackled with a regional approach.

Advantages of Serialisation
However, the benefits of serialisation go beyond just supply chain security.Using serialisation makes it possible to not only uniquely identify an object and track its movement within the supply chain, but also to assign attributes to the object, such as location and timestamps (for track and trace), temperature, humidity and all quality attributes such as production and process data, which would not be available on any counterfeit medicine. Once this data is collected and assigned, companies can respond to and manage the associated product information.

The specific objectives of serialisation depend on the application, and in the pharmaceutical industry such goals may be to check the authenticity of a product, prevent counterfeit products from entering the supply chain, improve product recall management, or even aid a complex investigation in the case of an adverse event or incident. As an example, counterfeit medicines, already widespread in the developing world, are now being found increasingly in the EU. While internet-based sales are the main source of counterfeit medicines, such products are also appearing in the traditional supply chain. Indeed, urgent measures are required to protect European patients, including a ban on medicine repackaging (3).

Clear Need For Patient Safety

In an attempt to deal with the increasing problem of counterfeit drugs and its clear implications for patient safety, the FDA cites RFID as a key technology to enhance consumer medication safety. Together with the development of the serialisation concept and the growth of an ePedigree solution, where a product has an electronic record of information that is authenticated and updated electronically as it moves through the supply chain, RFID is central in the ongoing battle for product transparency and security. Companies that have started to utilise this approach appear to be leading the way in terms of early adoption of item-level RFID and serialisation solutions. However, global adoption across the industry still remains at relatively low levels as companies have been slow to pick up on the business benefits already experienced by automotive and electronic giants.

Going forward it is clear that legislative requirements on drug companies will become even more stringent. It is believed that there is potential for mandatory measures such as drug authenticity (relating to its original certified manufacturing data) and ePedigree (a record documenting that the drug was manufactured and distributed under secure conditions) being implemented either in the US or on a global scale. It is certain that pharmaceutical companies will have to comply with such rules if they are to continue successfully developing, manufacturing and selling their products across the worldwide market.

Compliance with such requirements involves serious effort and investment. With the pharmaceutical industry facing increased pressures regarding time-tomarket, market responsiveness, cost reduction and manufacturing flexibility, the technology solutions to hand help satisfy the need for transparent information, business process improvements, product safety criteria and overall supply chain efficiencies. 

While RFID can offer real benefits, it is not limited to just pharma supply chain optimisation or pure track and trace applications; it also offers great potential across the entire pharmaceutical value chain.

Potential applications of RFID in life sciences

  • Product development – tracking of lab samples and patients, and usage of preclinical trials to support R&D functions
  • Asset management – identification and tracking of containers in the lab or during production, including container movement and history
  • Agile and flexible manufacture and production – inventory management, material tracking, production line management and process efficiencies
  • Supply chain – grey market tracking, protection against counterfeiting, product recall management, expiration date management, drug validation issues at point-of-sale and drug pedigree

Conclusion

For drug manufacturers, distributors, pharmacies and hospitals, RFID, serialisation and ePedigree can fully underpin the desire for improved operational efficiencies in their businesses by eliminating human failures, increasing product throughput and cutting costs. Transparent, accurate and timely information on all facets of drug manufacture and use is now readily available through technology that can link together the various elements of drug design, production, storage, transportation and dispensing. Not only do RFID and serialisation help in the task of continuous operational efficiency improvements so that competitive pressures can be overcome, they also assist the authorities in the ongoing global drug counterfeiting war.

It needs to be acknowledged that adoption of RFID technology has been limited to date in the pharmaceutical industry. Companies that have not embraced it should see the technology as a clear stepping stone to proven process improvements and as a pathway to a valuable understanding of their own business processes and how they operate, so that strategic and operational decisions can be made based on accurate information.

In addition, it will also lay a solid business foundation and provide product security across an industry which is seeing greater globalised regulatory control. It could be argued that the use of the type of technology outlined here lies at the very heart of the pharmaceutical industry’s ability to secure patient safety and satisfy consumer expectations for the future.

References

1. Siemens UK Life Science Event, Warwick, October 2010
2. Siemens Newsletter, ‘Serialisation for ePedigree’, March 2010
3. EFPIA position paper on European Commission’s proposal on counterfeit medicinal products, October 2009

 

 


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Dean Chespy studied Electrical and Electronic Engineering, and has an accomplished background with over 30 years in electronics and the pharmaceutical manufacturing industry. Having held senior engineering, advanced manufacturing and project management positions, his experience specialises in the implementation and use of automated high-technology solutions and advanced production methodologies. He has a proven track record in manufacturing excellence and the continuous improvement of a production company’s bottom-line results. As Siemens UK Life Sciences Development Manager, Dean’s role involves the coordination of a wide range of Siemens businesses that offer a value proposition through comprehensive expertise and cross-business solutions specific to the UK pharmaceutical and life science industry.
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