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Published by Narendrakumar

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Published by: Narendrakumar on Jan 08, 2009
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y oering companies a chanceto understand and control theirprocesses, both at the R&D andmanuacturing stages, PA enables con-tinuous quality verication and, with it,a chance to deliver consistent quality,lower costs, speed up product devel-opment and release, improve marketresponsiveness and reduce supply chainbottlenecks. Companies will also berewarded by a lighter regulatory touchi they can gain PA-led control o theproduct design space.Nonetheless, many companiesace diculties in implementing PAprojects. An important building block isto develop a clear ROI analysis. Such ananalysis delivers a number o benets—the objectives and implications o PAshould become clearer or the company;it should provide a clear ramework or investment and or evaluatingoutcomes; and the case or PA could bearticulated to top management and otherkey personnel within the company.
Starting Point –The full ROI context
 A vital starting point is or compa-nies to consider the ull context o PA. Only by doing so can compa-nies judge the true worth o PA. Tisrequires a consideration o the widerenvironment in which PA will be
Despite the advantages PAT offers to the pharmaceutical industry, many companies remainhesitant about its implementation due to high investment costs.
 A holistic approach
Ingrid Maes,
Consultant, Innovative echnologies,Competence Centre Phamaceutics, Siemens AG, Belgium
Figure 1
Th ROI cotxt of pharacticalPAT projct
R&D / Manufacturing ProcessesPharma CompanyStakeholders, Regulators, Patients
PAT/QbD System
M a n u f a c t u r i n g
78Pharma Focus asia
ISSUE - 6 2008
Companies need to identify the situations where PAT investmentis most likely to be cost-effective and be clear about the purposeand scope of the project as well as how it helps the company to achieve its longer term manufacturing vision and strategy. Thefollowing series of questions can help in such identification:
stratgic gai
– How does the PAT project fit with the company’swider product and manufacturing strategy? Also, what are theproject’s specific R&D or manufacturing benefits, such asoperational savings, faster time to market, increased machineavailability, less waste etc?
Rqird itt
– How much investment, including capitalexpense, planning and deployment, training, and ongoingmanagement and support, will the project require?
Fiacial rtr
– What are the expected financial returns of theproject, including ROI, savings and what is the payback period?
Key rOi Qesos
Opratioal fficicy
 – How will the PAT project contribute tooverall enterprise efficiency? Is the enterprise and knowledgearchitecture in place to capture these gains?
– What are the potential risks associated with the project?How likely are they and what contingencies need to be in place?What would be the impact on the financial return and strategicgains?
Coptiti ad rptatioal ipact
– What competitiveadvantage can be gained? What are the reputational implicationsof investing or not investing in PAT? How does the proposedinvestment compare with competitor’s PAT plans?
Accotability ad owrhip
– Who is accountable for theproject’s success? Is the project owned by top management? Is there sufficient leadership to deliver the change in working methodsand culture that will be needed for the project to be successful?
implemented (Figure 1), not just look-ing at quality and process control butgoing ar beyond this to consider regu-latory relationships, the needs o health-care organisations and, ultimately, thelinks with patients. An important parto the US Food and Drug Administra-tion’s vision or PA, or example, is thatthe adoption o the technology by thepharmaceutical industry will help closethe gap between drug product develop-ment and the patient. In the uture,it is hoped that PA will be part o aeedback loop that can enable compa-nies to take account o how a specicdrug is perorming in specic patientcontexts and adjust ormulations andmanuacturing accordingly.In addition to these uture visions,the development o PA and decisionsabout the best roll-out o the technol-ogy needs to be taken in the contexto a company’s current and projecteddrug portolio, reecting the dierentmanuacturing needs o products thatare in the pipeline. In other words,decisions on PA cannot be takenaway rom the context o the threekey major elements—the company’suture business and product strategy, itsorganisational setting and external envi-ronment. However, in my experience,this consideration o wider external orinternal context oten does not takeplace when it comes to PA projectsin pharmaceutical companies. Compa-nies requently view PA in exactly theopposite way, deciding to buy a coupleo tools to replace existing lab measure-ment methods and see where that leadsthem.Tis consideration o contextoutlined in Figure 1, in turn, leads tosome o the parameters or the ROIanalysis both on the cost and thebenets side. For example, investmentin PA should be expected to delivertangible perormance improvementsin R&D and manuacturing processes,such as reduced waste, aster through-put times and, ultimately, the potentialor real-time product release. At thesame time, there will be wider company implications, such as retraining or rede-ployment whose costs will need to beully actored in.
Rooting ROI in strategic ambition
Te design and extent o the ROIanalysis will be largely determined by the extent o strategic ambition behindthe PA implementation. Tere isa big dierence between a company that is seeking to develop PA in agreeneld setting, aiming or ull real-time product release, and a company that is seeking to improve an existingaspect o manuacturing, perhaps on asingle unit operation such as drying. Inmany situations, companies can start with a small application o PA onone part o the production process, orexample on a single unit operation suchas drying, beore moving on to a moreglobal view. A typical start point, orexample, might be the establishment o an end-point detection or a dryer orgranulator. Indeed, in our experience,the most common applications o PArelate to online monitoring o blending,drying and granulation steps.In all instances, the goal should besome clearly identiable perormanceimprovement. However, as discussed,many companies do not even startby identiying such clear change butinstead all into the trap o seeing PAmerely as an alternative to existingactivities, or example investing in anin-line process analyser as a replacement
M a n u f a c t u r i n g

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