Pharma 4.0 – time to rethink manufacturing and quality · portfolios. Manufacturing...
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portfolios. Manufacturing individualised drugs on a smaller scale is a challenge with several constraints when securing process robustness and proving stability on batch level. Second, cost pressure and globalisation have led to increased outsourcing activities and, as a result, a highly complex supply chain. Although the cost of goods sold may be optimised, quality risks increase due to lack of global oversight and less control over end-to- end processes. Last, but not least, counterfeiting is a serious problem. Initially a phenomenon in developing countries, free global trade has brought counterfeit drugs back to the originators’ core markets. Stricter regulations have been introduced in different geographies without leading to common standards for track-and-trace solutions. Quality and compliance In a Pharma 4.0 world, there is no room for nostalgic paper filing, and a virtual value chain relies on seamless, real-time data exchange. Data integrity is high on the priority list of regulators and, considering the enormous amounts of data generated, this can only be secured by having one single source of truth. In contrast to the traditional paper- centric approaches, data management is not just about compliant record keeping. By leveraging Cloud-based data management and advanced analytics, key information can be generated going beyond compliance and supporting quality decisions and continuous improvement. Because all critical data resides in a GxP-regulated cloud, quality professionals will have the visibility and The emergence of the Internet has fundamentally transformed many industries, however, it is only since the rise of the Industry 4.0 concept that the digital revolution has reached the core of industrial manufacturing. Robert Gaertner, Director of Strategy for Quality and Manufacturing, Veeva Systems, Europe considers its potential use within the pharmaceutical sector 52 manufacturing chemist December 2015/January 2016 The idea behind Industry 4.0 is to connect human resources, data, and physical machines in a cyber-physical network. Physical assets such as smart robots will adhere to common standards, enabling flexible pre-configuration on- the-fly and modular replacement of resources. A key component of the concept is the ‘Internet of Things’, which will establish intelligent machine-to- machine connectivity within and beyond company walls. One of the key benefits of Industry 4.0 is that it best addresses the increasing need for individualised products, while dramatically improving productivity and lead times. On the other hand, large investments in the introduction of multiple new technologies will be required. For example, Cloud-based data management and advanced analytics are fundamental components, as full system integration will lead to enormous data volumes that need to be analysed and shared across the virtualised value chain. Weighing costs and benefits, Industry 4.0 principles will initially be adopted by those industries that, based on market demands, have moved away from mass production and diversified to serve smaller segments with more tailored product offerings. Looking at the current state of pharmaceutical manufacturing, it seems that a paradigm shift in technical operations would be a good pill to swallow. In the past decade, the environment for manufacturing and quality has become more challenging for various reasons. First, there is the shift from the one- drug-fits-all approach towards individualised therapies. Without a doubt, personalised medicine with specialised drugs for smaller patient groups can significantly improve the effectiveness of treatments. Hence, this rising market demonstrates true innovation and is an opportunity for life science companies to secure their revenue streams by diversifying their Pharma 4.0 – time to rethink manufacturing and quality “By leveraging Cloud-based data management and advanced analytics, key information can be generated going beyond compliance and supporting quality decisions and continuous improvement” MANUFACTURING
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Transcript of Pharma 4.0 – time to rethink manufacturing and quality · portfolios. Manufacturing...
portfolios. Manufacturing individualiseddrugs on a smaller scale is a challengewith several constraints when securingprocess robustness and proving stabilityon batch level.
Second, cost pressure and globalisationhave led to increased outsourcingactivities and, as a result, a highlycomplex supply chain. Although the costof goods sold may be optimised, qualityrisks increase due to lack of globaloversight and less control over end-to-end processes.
Last, but not least, counterfeiting is aserious problem. Initially a phenomenonin developing countries, free global tradehas brought counterfeit drugs back to theoriginators’ core markets. Stricterregulations have been introduced indifferent geographies without leading tocommon standards for track-and-tracesolutions.
Quality and complianceIn a Pharma 4.0 world, there is no roomfor nostalgic paper filing, and a virtual
value chain relies on seamless, real-timedata exchange. Data integrity is high onthe priority list of regulators and,considering the enormous amounts ofdata generated, this can only be securedby having one single source of truth.
In contrast to the traditional paper-centric approaches, data management isnot just about compliant record keeping.By leveraging Cloud-based datamanagement and advanced analytics, keyinformation can be generated goingbeyond compliance and supportingquality decisions and continuousimprovement. Because all critical dataresides in a GxP-regulated cloud, qualityprofessionals will have the visibility and
The emergence of the Internet has fundamentally transformed many industries, however, it is onlysince the rise of the Industry 4.0 concept that the digital revolution has reached the core ofindustrial manufacturing. Robert Gaertner, Director of Strategy for Quality and Manufacturing,Veeva Systems, Europe considers its potential use within the pharmaceutical sector
52 manufacturing chemist December 2015/January 2016
The idea behind Industry 4.0 is toconnect human resources, data, andphysical machines in a cyber-physicalnetwork. Physical assets such as smartrobots will adhere to common standards,enabling flexible pre-configuration on-the-fly and modular replacement ofresources. A key component of theconcept is the ‘Internet of Things’, whichwill establish intelligent machine-to-machine connectivity within and beyondcompany walls.
One of the key benefits of Industry 4.0is that it best addresses the increasingneed for individualised products, whiledramatically improving productivity andlead times. On the other hand, largeinvestments in the introduction ofmultiple new technologies will berequired. For example, Cloud-based datamanagement and advanced analytics arefundamental components, as full systemintegration will lead to enormous datavolumes that need to be analysed andshared across the virtualised value chain.
Weighing costs and benefits, Industry4.0 principles will initially be adopted bythose industries that, based on marketdemands, have moved away from massproduction and diversified to servesmaller segments with more tailoredproduct offerings.
Looking at the current state ofpharmaceutical manufacturing, it seemsthat a paradigm shift in technicaloperations would be a good pill toswallow. In the past decade, theenvironment for manufacturing andquality has become more challenging forvarious reasons.
First, there is the shift from the one-drug-fits-all approach towardsindividualised therapies. Without adoubt, personalised medicine withspecialised drugs for smaller patientgroups can significantly improve theeffectiveness of treatments. Hence, thisrising market demonstrates trueinnovation and is an opportunity for lifescience companies to secure theirrevenue streams by diversifying their
Pharma 4.0 – time to rethinkmanufacturing and quality
“By leveraging Cloud-based datamanagement and advancedanalytics, key information can begenerated going beyond complianceand supporting quality decisions andcontinuous improvement”
MANUFACTURING
052-053mc1215Veeva a.qxp_Layout 1 08/01/2016 14:36 Page 52
MANUFACTURING
access they need to monitor qualitymetrics, make fact-based qualitydecisions in a timely manner, supportedby predictive analytics on qualityparameters.
New ways of managing GxP-criticalinformation is key,but this is only oneexample oftechnologicaldevelopments thatface quality andcomplianceprofessionals. Toget ahead of thesetopics, decision-makers shouldacquire deepunderstanding ofopportunities andrisks associatedwith new concepts
such as Industry 4.0 – not all aspects of itmay be applicable to the highly regulatedlife sciences industry. In the future,quality should become a trusted advisorin terms of implementing newtechnological concepts in GxP-regulatedareas, from a compliance perspective but
also taking into consideration qualityimprovement opportunities and threadsfor all virtualised operations.
Many life sciences companies havestarted to introduce some newtechnological capabilities inmanufacturing, but without a moreholistic strategy regarding GxPcompliance, the value will not be fullyunleashed. Industry 4.0 is a well-thought-out concept for modernising technical
operations, and corporate quality canplay a key role in leveraging it. Pharma4.0 would not only lead to productivitygains and secure competitive advantage,but also significantly improve therobustness of product quality and thesecurity of the supply chain to thepatient.
In summary, pharmaceuticalmanufacturing and quality operationsnowadays are suffering from the fact thatthey are obliged to serve a businessmodel for which they were not originallydesigned. In addition, traditionalinterpretations of GxP compliance havecemented inflexible barriers and ways ofworking that slow down adoption oftechnological innovation.
It is the right time for the nextindustrial revolution and a radicalrevamping of technical operations fromthe inside out. Based on the commonprinciples of Industry 4.0, a Pharma 4.0initiative would not only fix agility andproductivity issues, but also providequality operations with betterinstruments to enforce product safetyand supply chain security.www.veeva.com/eu
“A Pharma 4.0initiative wouldnot only fixagility andproductivityissues, but alsoprovide betterinstruments toenforce productsafety andsupply chainsecurity”
December 2015/January 2016 manufacturing chemist 53
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