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Manufacturing & Logistics IT spoke with Paul Woodcock and Prasanna Pant from Tata Consultancy Services about a range of current issues and concerns within the pharmaceutical sector, and how reputable consultancy practices can help ensure good practice is adhered to throughout the companys manufacturing and supply chain processes.
Pharmaceutical manufacturing is one of the most demanding of all industry sectors in terms of regulatory and market pressures. To address these challenges, major pharmaceutical companies are increasingly transforming themselves into an extended enterprise from the traditional manufacturer & supply chain model. From drug discovery & development, sourcing raw materials, bulk drug manufacturing, formulation and drug delivery through to delivering to the end customer, everything has to be traceable and validated so that at any point the company can prove that it has followed approved processes.
Tata Consultancy Services Paul Woodcock explains that, as well as the plethora of regulations in different countries, the pharmaceutical industry also has a raft of recommended good practice guidelines to comply with. In fact, this is becoming more of a minefield in the wake of an increasing number of companies moving their manufacturing operations from the US and Europe into countries such as China and India, he said. And because accepted standards of good practice in the West can sometimes be slower to take hold in some countries, controlling bodies such as the Food & Drug Administration (FDA) are getting increasingly stretched because there are only so many inspectors that they have available to monitor procedures in these areas. The FDA is already setting up offices in China and India to better regulate drug manufacture at the source of supply.
Woodcock adds that there is also the problem of illegal counterfeiting of prescription drugs to contend with. This is becoming a bigger and bigger concern as is evidenced by a number of cases of such practices over the past few years, he said, adding that a conservative estimate places the amount of counterfeit drugs as high as 10 per cent of total global sales volume. Companies are understandably worried about this, partly because these drugs only have a limited patent lifetime in which the pharmaceutical companies can benefit financially from a product that has spent many years in development, continued Woodcock. He points out that there is also the issue of R&D and securing a products successful introduction to the marketplace. If theres one thing that keeps a chief executive of a pharmaceutical company awake at night its his pipeline of new drugs, which may have taken his company some 12 years or so to get into the marketplace only to fail a clinical trial or not get approval, because you can be talking about many millions of dollars per drug, he said. And because most of the R&D is undertaken in the West, Woodcock highlights the fact that there is the whole issue of transferring all the formulation and production-related data from the West to the production plant in a country in the developing world, which, he points out, can be a very different environment.
One of the many tasks TCS regularly gets involved in within the pharmaceutical industry is helping companies manage and assess clinical trial data. And Woodcock is keen to stress that once a product is successfully trialled and launched to market, things dont stop there. When a drug is already in the marketplace, there are large volumes of data gathered from doctors and hospitals all around the world related to any adverse effects reported by patients, he explained. Indeed, we employ statisticians and medical people to look at this type of data and advise pharmaceutical companies as to whether they have a problem, whether large or small. This could involve anything from withdrawing a drug from the marketplace completely to softer options such as re-formulation or amending the advice to medical staff prescribing the drugs.
Fit for purpose
And what of software solutions within the pharmaceutical arena? TCSs Prasanna Pant stresses that every piece of software used by a pharmaceutical company has to be fully validated and deemed fit for purpose. Therefore, using industry standard 3rd party software that have been developed and pre-validated for use within a pharmaceutical environment under the Code of Federal Regulations (CFR) 21 Part 11 can prove to be considerably more straightforward than choosing more bespoke alternatives, he said, adding: It is also worth pointing out that if the pharmaceutical company develops a piece of software to interface with its legacy applications or to interface with a third-party application this would also need to undergo computer systems validation. Pant explained that mandatory computer system validation encompasses both the hardware and software that a pharmaceutical company uses within its manufacturing environment. This validation process falls under rules related to electronic records and electronic signature as outlined in CFR 21 Part 11, he said. As a consultancy, TCS regularly advises on various software and business solutions that aid a pharma company in optimising its manufacturing and supply chain processes. There are all kinds of solutions that we often advise on, from basic shop floor process control right up to Manufacturing Execution Systems, and Enterprise Resource Planning solutions such as SAP and Oracle, looking over the whole of your supply chain, said Woodcock. The most important aspect to this is that each software module and the interfaces have to be validated and tightly coordinated so data can pass as seamlessly as possible from one layer to the next.
Pant pointed out that TCS has also developed targeted industry solutions based on its domain experience in pharma and other lifescience sectors; such as medical devices to address the requirements of 21 CFR Part 11, CFR Parts 210-211 and CFR Part 820. He points out that over 20 per cent of a pharma companys costs are from manufacturing alone, most of which is outsourced hence the need for solutions addressing the changed paradigm of supply chain for pharma manufacturing. According to Pant, another important trend driving manufacturing efficiency has been triggered by the FDAs initiative called GMPs for the 21st Century. He maintains that this has led to companies such as TCS looking at solutions for Process Analytical Technology (PAT) and Quality by Design (QbD), which are gaining importance in the pharma sector and seen as the only ways to improve Time to Market and Time on Market, as well as manufacturing agility important metrics for a pharma company trying to maximise the 20-year patent lifecycle for products.
From a logistics and supply chain standpoint, Pant explained that consultancies such as TCS are able to support pharmaceutical companies by advising on a variety of pure supply chain-related requirements; for example, those involving the tracking and tracing of goods. Accurate track and trace capability is currently only a good practice guideline within sectors such as pharmaceutical, but it is slowly becoming a must-have supply chain asset, said Pant. The means to secure an accurate track & trace regime could be in the form of barcoding solutions or emerging technologies such as RFID. It could even be, in part, in the form of smart labels, which will be increasingly recognised as beneficial in preserving and providing information related to the genealogy and labelling of a product.
Interestingly, Woodcock added that the way a drug is prepared and delivered for different regions throughout the world, because of cultural differences, can be quite distinct; so pharma companies basically need to be able to package and formulate the drug differently for different territories. Woodcock also pointed out that within the supply chain itself there are things such as expiry dates to consider. Of course, some drugs need to be kept refrigerated, and if youre contracting out part of your logistics operations to third parties you need to make sure the right carefully controlled conditions are going to be maintained once the goods change hands.
In conclusion, Woodcock reflects that the pharmaceutical sector has always been one of the most complex industry verticals. In recent times this complexity has been compounded by ever more stringent regulatory requirements and the greater intricacies of extended supply chain. However, with the right methodologies and professional guidance in place, pharmaceutical manufacturers can remain legally compliant, forward thinking, successful and efficient.