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TECHNOLOGY CAN DELIVER PHARMA INDUSTRY OPERATIONAL EFFICIENCY AND UNDERPIN CONSUMER CONFIDENCE

Radio frequency identification

Radio frequency identification (RFID) provides access to transparent and accurate information to help pharmaceutical companies tackle a number of key business issues. They include ensuring patient safety and product security at all times; an increasing globalised market; the need to improve production and process efficiencies to cut costs, as well as addressing the overall effectiveness of the industry supply chain – from a drug’s development through production and distribution to point of sale.

Dean Chespy – Life Sciences Development Manager for Siemens Industry Automation, highlights the business benefits RFID can deliver for the pharmaceutical industry, touching on the growth of concepts such as Serialisation and ‘ePedigree’ as the latest technology to help improve operational processes and market traceability. He says that companies employing RFID will see improved operational efficiencies; have a better understanding of their processes and businesses and can develop a base to start to tackle cost concerns. As an associated benefit it can also protect companies as they work under a legislative spotlight designed to guarantee drug product safety and underpin consumer confidence globally.

Ever-changing competitive, legislative and economic pressures on pharmaceutical manufacturers mean businesses are confronting two key market drivers. These are the need to improve production and process efficiencies to reduce costs and encourage competitive advantage, as well as dealing with the industry effects of market globalisation. Proven technology developments such as 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.

Virksomhederne er nødt til at øge driftseffektiviteten og skabe fleksibilitet i fremstillingen med et kæmpe øje med omkostningerne for at sikre, at de kan levere hurtige problemfri produktionsomlægninger til at reagere på at ændre markedspåvirkninger og tendenser. De har også brug for at beskytte sig mod det stigende niveau af regering og lovgiver kontrol, at på den globale marked er stærkt fokuseret på patient og produktsikkerhed. Dette er i sammenhæng med en fortsat verdensomspændende handel med forfalskede stoffer, der i øjeblikket tegner sig for 5% af alle solgte stoffer (1).

RFID is in many ways not a new technology. It employs ‘smart tags’ to track, trace and identify every type of item and has been in some form of use 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 clear 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. First, a tag (chip + antenna) which is attached to the physical entity in question. Secondly, a reader which can ‘read and write’ data from and to 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 attached tags 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 bar-coding solutions which have to link back to a central database.

RFID-tags kan bruges i en række formater, f.eks. I gentagelsesfremstillingsoperationer, såvel som i engangsemballageformater med oplysninger, der er tilgængelige i pakkenes levetid. Mærker i sådan brug bliver mere udbredte og bliver mere og mere omkostningseffektive, da de giver mulighed for at spore og spore varer over hele ende-til-ende forsyningskæden.

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 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, the ability to use such information can be utilised as a key tool for product authentification – which is a weapon to combat grey market, theft and drug counterfeiting activity.

Serialisering

Drevet til at øge standarderne for produktsikkerhed for pharma-virksomheder har ført til vækst og vedtagelse af begrebet serialisering som næste fase, der bygger på fordelene, der er klart set og afledt af RFID-teknologi. Efterhånden som globaliseringen på tværs af medicinalindustrien øges, er det også kompleksiteten af ​​sin forsyningskæde, der stiller nye udfordringer op og potentielt bringer nye niveauer af sårbarhed over for virksomheder, der udvikler, fremstiller, distribuerer og dispenser stoffer. På grund af berygtede episoder vedrørende forfalskede eller forfalskede produkter har regeringerne ført til vejen for at sikre forsyningskædesikkerhed en høj prioritet, og som et middel til at vedtage og implementere sporbarhed har politikere og lovgivere opfordret til at sætte gang i indførelsen af ​​item-level serialisering.

Serialisering er en proces med at identificere et objekt med et unikt serienummer, der kan udveksles universelt. Inden for lægemidler kan det anvendes på hver enkelt genstand, et tilfælde og et palle af et lægemiddel til at autentificere det enkelte produkt og muliggøre sporing og sporing (og opbygning af stamtavle) indenfor forsyningskæderne hos producenter, distributører og grossister.

The requirements for Serialisation are growing in the USA and Europe, and have included the FDA developing a standardised numerical identifier in the United States. Nearer to home, the European Federation of Pharmaceutical Industries and Associations (EFPIA) – through its 31 national pharmaceutical industry associations and 44 leading pharmaceutical companies – are adopting a pilot coding solution for Europe(2). This is to perform product authentification at the point of dispensing with a serialised Data Matrix 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 very much with a regional approach.

Men fordelene ved serialisering går ud over kun forsyningskædesikkerhed. Gennem serialisering er det ikke kun muligt at identificere et objekt unikt og at spore objektets bevægelse i forsyningskæden. Det er også muligt at tildele objektet attributter, som f.eks. Placering og tidsstempler (for spor og spor), temperatur, fugtighed og alle kvalitetsattributter som produktions- og procesdata, hvilket ikke ville være tilgængeligt på nogen forfalsket medicin. Når disse data er indsamlet og tildelt objektet, kan virksomheder reagere på og administrere de tilhørende produktoplysninger.

De specifikke mål for serialisering afhænger af ansøgningen, og i lægemiddelindustrien kan sådanne mål være at kontrollere ægtheden af ​​et produkt, forhindre forfalskede produkter i at komme ind i forsyningskæden, forbedre produktrekaldsledelsen eller endog hjælpe en kompleks undersøgelse i en sag af en uønsket hændelse eller hændelse. Som et eksempel findes forfalskede lægemidler, der allerede er udbredt i udviklingslandene, i stigende grad i Den Europæiske Union. Mens internetbaseret salg er den vigtigste kilde til forfalskede lægemidler, vises sådanne produkter også i den traditionelle forsyningskæde. Faktisk er der brug for hasteforanstaltninger for at beskytte europæiske patienter, herunder forbud mod ompakning af lægemidler (3).

In an attempt to deal with the increasing problem of counterfeit drugs and its clear implications for patient safety, the FDA in America 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 product security. For those companies who have started to utilise such an approach, it appears they are leading the way in terms of early adoption of item-level RFID and Serialisation solutions. However, global adoption generally 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.

Det fremgår klart, at lovkravene på narkotikaproducerende virksomheder vil blive endnu strengere. Det antages, at der er et reelt potentiale for obligatoriske foranstaltninger som narkotikarentitet (relateret til dets oprindeligt certificerede fremstillingsdata) og elektronisk stamtavle (en dokumentation for, at stoffet blev fremstillet og distribueret under sikre forhold), der blev implementeret enten i USA eller på globalt plan. Det er sikkert, at medicinalvirksomheder skal overholde sådanne regler, hvis de skal fortsætte med at udvikle, producere og sælge deres produkter i store dele af verdensmarkedet.

Overholdelse af sådanne krav kræver seriøs indsats og investering. Med den farmaceutiske industri står over for øget pres med hensyn til time-to-market, markedssvarlighed, omkostningsreduktion og fleksibilitet i fremstillingen, hjælper de teknologiske løsninger til hånden behovet for gennemsigtige oplysninger, forbedringer af forretningsprocessen, produktsikkerhedskriterier og overordnede forsyningskædeseffektiviteter.

Mens RFID kan tilbyde reel fordel, er det ikke kun begrænset til pharma supply chain optimering eller ren spor og spor applikationer. Det giver stort potentiale i hele den farmaceutiske værdikæde, som nedenstående tabel illustrerer:

Potentielle anvendelser af RFID i biovidenskab nævnes:

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

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 does RFID and Serialisation help in the task of continuous operational efficiency improvements so that competitive pressures can be overcome, they also aid 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 haven’t embraced it should, in my view, see the technology as a clear stepping stone to proven process improvements and a pathway to a valuable understanding of their own business processes and how it operates, 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.
Referencer

1. Siemens UK Life Science Event, Warwick – October 2010
2. Siemens Newsletter – ‘Serialisation for ePedigree’ – March 2010
3. Siemens UK Life Science Event, Warwick – October 2010

Siemens Automation Industry – Manchester
Kan kontaktes på
Tlf: 0161 446 6400 eller Web: www.siemens / automation.com

Siemens Industry

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