Supply Chain Integrity and Security

Supply Chain Integrity and Security

The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our attention to supply chain integrity and deal with both security and integrity concurrently.

An Oxford on-line dictionary definition of integrity is “the state of being whole and undivided”. Over the last 40 years, the Pharma supply chain has fragmented to the point where it is a million miles from that state. There are now multiple business models, such as virtual, biotech, specialty Pharma, innovator, generics, biosimilars, etc and a divergence of supporting actors, such a contract manufacturing organizations (CMOs), contract research organizations (CROs), central laboratories, third party logistics providers, pre-wholesalers, wholesalers, specialty pharmaceutical providers (SPPs) etc. As a result, our supply chains have dis-integrated to the point where visibility and accountability have become blurred at the edges – and it is this disintegration that has opened the doors to criminal activity and errors in quality outcomes.

The solution is not an easy one. It requires urgent action to mitigate activities of the ‘bad guys’, together with a longer term approach to ensure the ‘good guys’ get better at building and managing robust supply chains. This can only be achieved by collaboration between regulators, other enforcement agencies, technology providers and the industry itself. Where do we start?

We must initially focus on the end-to-end supply chain in its current state. Chains of custody and ownership must be clearly identified and remediation actions agreed by responsible parties to plug the gaps that currently exist. For example, Quality and technical agreements must become far more ‘process’ orientated so that they become working documents shared between business partners, rather than merely a static list of tick boxes. Change control has to work on upstream and downstream impacts that might affect supply chain integrity and procurement must forge supply agreements that impose obligations for supply chain visibility on prospective partners. This and much more needs to happen and will be discussed in the session.

Then we must turn attention to the building of supply chains for the future – the product development phase. This industry is unique in that the entire supply chain must be registered with competent authorities before approval to sell and post-launch changes have to be approved. This places a great responsibility on getting it right from the start. This is where the opportunity lay for sustainable improvements in the physical architecture of the supply chain and the underpinning management processes and information flows. A foundation for this has already been put in place by the regulators through FDA’s 21st Century Modernization initiative and ICH Q8 – 11 guidelines. The key to translating these initiatives into meaningful supply chain improvements, however, it in understanding the patient value proposition and the organizational/cultural elements that must firstly be in place, and these are explored in some depth.

Why should you attend: The Pharmaceutical supply chain has never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Cargo theft, diversion and counterfeiting have become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.

Areas Covered in the Session:

  • How to organize for supply chain integrity throughout the product life cycle
  • Current approaches to clamping down on criminal activity in the supply chain
  • Issues causing greatest concern to regulators and how to address them
  • Role of ICH Q8 – 11 in building robust supply chains
  • How the disciplines of procurement and supply chain management (SCM) can be leveraged
  • Role of technology as an enabler

Who Will Benefit:

  • Research chemistry and biochemistry
  • Chemical and biochemical engineering
  • Chemistry, manufacturing, and controls
  • Preclinical Development
  • Clinical Development
  • Regulatory Affairs
  • Quality Assurance

Speaker Profile

Hedley Rees is a practicing consultant, coach and trainer, helping healthcare companies build, manage and continuously improve their clinical trial and commercial supply chains and risk profiles. He has his own company, Biotech PharmaFlow Ltd, based in the UK and handles assignments across the spectrum from top ten Pharma’s through to highly virtual early stage start ups. Prior to this, Hedley held senior supply chain positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of supply chain management processes from strategic procurement, production and inventory control, distribution logistics, information systems and improvement. His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernization and ICH Q8 – Q10.

Hedley holds an Executive MBA from Cranfield University School of Management and is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS). He is a member of the UK BioIndustry Association’s (BIA) Manufacturing Advisory Committee and also regularly speaks at international conferences, being co-chair of the 2011 FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati, October 2 -5. He has published in US and EU pharmaceutical journals and is author of “Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics” published by J. Wiley & Sons, Hoboken, New Jersey.

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Risk management methods and tools in the pharmaceutical and life sciences industries

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Understanding and implementing risk management methods and tools is crucial for the pharmaceutical and life sciences industries in view of the fact that errors in this area can lead to dangers for human life. Since any mistake in any chain of in this industry can lead to serious consequences; the FDA and other regulatory agencies have created a number of risk management methods and tools for these industries.

A few commonly used risk management methodsIn the pharmaceutical and life sciences area, a few commonly used risk management methods and tools for organizing data and using these to help in decision-making include the following:

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A few popular risk management methods and toolsIn the field of pharmaceuticals and life sciences, these can be said to be some of the more popularly used risk management methods and tools:

Failure Mode Effects Analysis (FMEA)FMEA is a popular one among the risk management methods and tools mainly because it provides a methodology for assessing a potential failure mode for the process that goes into the manufacturing of the pharma or life sciences product and helps to analyze their possible impact on the product’s ability to perform to its required standard.

risk-in-pharmaceutical-and-life-sciences-industriesIdentification and establishment of failure modes are taken as the basis for using risk reduction techniques for eliminating, containing, reducing or controlling the possible failures. Since FMEA depends on a deep understanding of the product and the process; its main steps include dissembling complex processes into simpler and comprehensible ones. For this reason, FMEA is considered a potent risk management method and tool.

Failure, Mode, Effects, and Criticality Analysis (FMECA)Extending the concept of FMEA a little farther, the Failure, Mode, Effects, and Criticality Analysis (FMECA) takes into account the added feature of the extent of gravity of the consequences of a fault or failure, along with the possibility of their occurrence, as well as the chance of their detection. While this is the slight extension that the FMECA brings to FMEA; it is similar to it in other respects, namely:

risk-in-pharmaceutical-and-life-sciences-industriesFMECA too, like FMEA, uses identification and establishment of the process specification to identify risks and failures

FMECA too uses the method of breaking down difficult processes to easier ones to enable better understanding of the failures and risks.

Fault Tree Analysis (FTA)Fault Tree Analysis is another of the risk management methods and tools. What this tool does is that it takes up a single fault at a time for analysis, but links the chains that cause the fault. This is why it gets its name, wherein the results of the analysis are represented in a shape of a tree, in which each level of fault is described with possibilities. A sharp and incisive analytical bent of mind is required to create the FTA.

Hazard Analysis and Critical Control Points (HACCP)HACCP is yet another important one among the risk management methods and tools. It takes a systematic and proactive approach in ensuring the following in a product:

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It is considered a comprehensive risk management method and tool because it addresses all the issues relating to risk management methods and tools, applying scientific principles and methods for carrying out the following:

risk-in-pharmaceutical-and-life-sciences-industriesControlling of the risk or the negative outcomes of hazard, which could be due to any of these:

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Supporting statistical tools
risk-in-pharmaceutical-and-life-sciences-industriesWhile all the risk management methods and tools described above are a snapshot of some of the major ones, a few supporting statistical tools, too, are used to engender quality risk management. These are some of them:

 

 

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How to choose a supply chain management solution

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Any business that opts for a supply chain management solution has to have clarity on how to choose a supply chain management solution. This is because the supply chain management solution is expected to carry out a number of very important functions. Choosing the wrong or inappropriate one can backfire on the business and derail and impede, rather than ease its work.

Businesses have to take a few important factors into consideration when they have to choose a supply chain management solution. For the supply chain management solution to perform its function of facilitating the supply chain for the business, it needs to perform its functions smoothly without causing hiccups to the business. This is where the decision-making ability of the business owner comes into picture.

supply-chain-management-solutionSo, what factors need to be taken into consideration when a business has to choose a supply chain management solution? Try considering these:

1. Choose by industryThis is obviously a no brainer, but it is an important first consideration nevertheless in choosing a supply chain management solution. Many supply chain management solution providers sell the idea that these are one-size-fits-all solutions that work across a number of industries since the core functions are essentially the same.

This may be true to an extent, but while a number of functionalities are common across a few industries; it is important to get down to the one that is built for your business. A supply chain management solution that works best for retail, for example, may not be as effective for an automobile store. Getting down to the details and dissecting the functionality that the supply chain management solution performs for your particular industry is an important first step in choosing a supply chain management solution.

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2. Define your needThis is the next important consideration when choosing a supply chain management solution. A number of supply chain management solutions are available in the market. Choose the one that suits your need the best. In order to do this, the business has to define its need to the fullest extent. It could take a few factors such as this into consideration:

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3. Understand the integration function of the supply chain management solutionIntegration is, well, the very soul of a supply chain management solution. The business should have clarity on what functions need to be integrated into the supply chain management solution. The reason for which the integration function is built into a supply chain management solution is to facilitate synchronization of the whole chain. This makes it one of the core factors that determined how to choose a supply chain management solution.

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4. Insist on the visibility featureVisibility is a great means for the business to have control over its sales, inventory, logistics, and a host of other functions. The supply chain management solution has to offer visibility on all these functions.

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5. Customer relationship management (CRM)A supply chain management solution is incomplete if it does not come equipped with a strong CRM feature. The CRM is the determinant in helping to establish a good relationship with the customer. The CRM feature should enable the business to completely understand the nature of the orders and their status, plus, more importantly, help in customer query responses and other important customer-related features.

 

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Trends that will shape Supply Chain and Logistics in 2017

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Trends that will shape Supply Chain and Logistics in 2017 is an interesting topic to think about. Though most of the trends are a takeoff from the previous years, unless something really disrupting happens out of the blue at some point of time in the year; the signals are strong that the trends that emerged in the previous few years are set to solidify and get reinforced.

What are the trends that will shape supply chain and logistics in 2017?

For a sector that is dependent heavily on infrastructure for its working; there has been little of path breaking significance in terms of what has been added to the existing infrastructure in any country of significance in the world, at least not to the extent that it can impact the industry in a significant way. The Chinese hobbyhorse, the One Belt One Road (OBOR) initiative, is not slated for completion in this year. The completion of this grand project could spell a major change for the shape supply chain and logistics, but nothing of such drastic significance is set to take place in 2017.

trends-will-shape-supply-chain-and-logistics-2017In the other “happening” countries – for the supply chain and logistics industry that is – 2017 is not likely to see a signal shift. But the developments that have been happening over the past few years are likely to gather pace. Technology is one area in which the change is to be expected. While again, technology itself may not really be new till this point of time in this year; a few trends have been emerging, promising to make some impact on the shape supply chain and logistics industry in 2017.

Big Data as a driver of changeBig Data is the word on everyone’s lips. How can one expect an industry that is so completely data driven as logistics and supply chain to be insulated from its influence?

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Transition to m-commerceA notable development that is expected in the supply chain and logistics in 2017 is the evolution of ecommerce into m-commerce. This again, is nothing new or defining for 2017, but the year is likely to see a continuation of the trend set earlier.

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People all over the world are finding it much easier to shop with the help of their mobile devices, and are adapting to this medium, albeit at different levels and speed. The explosion in the number of smartphones being purchased globally has added impetus to m-commerce.

Try-ons as a new trendA new feature of online shopping is the try-on option that consumers are now being given. Online shoppers are given the option of choosing 4-5 varieties of their chosen product. All these pieces are delivered with the order, and the consumer can try out each of them and select the one that she thinks suits her best. The idea is to replicate the actual shopping to the extent possible.

trends-will-shape-supply-chain-and-logistics-2017This trend has its challenges, for sure, because the cost of making it work could be unimaginably high. As with any new trend, it is going to be some time before the economies of scale of such huge logistical operations start kicking in. Yet, this is a very tangible factor that is sure to count among the supply chain and logistics trends of 2017.

 

 

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Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about by globalization, namely outsourcing, has further increased the need for global supply chain regulatory compliance.

Global supply chain regulatory compliance has now become something on which organizations cannot compromise. Any shipment of any item that reaches foreign shores can get rejected if it has not met global supply chain regulatory compliance. Such a consignment could even get labeled as counterfeit. This explains the importance and need for global supply chain regulatory compliance. Being in global supply chain regulatory compliance means adhering to even the local laws of the foreign country into which goods and products are exported.

Governments have become more stringent 

global-supply-chain-regulatory-complianceAs a result of these trade and technological developments; governments all around the world without exception are jumping on the bandwagon to formulate laws that apply to the supply chain industry. For most governments, global supply chain regulatory compliance is a must. They are becoming extremely strict in enforcing these laws and are handing out severe punishments to businesses and organizations that are lax in enforcing global supply chain regulatory compliance. Most countries are legislating laws regarding global supply chains almost exclusively, in a way that other political acts are framed. This has pushed the need for global supply chain regulatory compliance further.

Other related developmentsAs technologies advance in the global supply chain, many developments in auxiliary and supplementary fields have hastened global the push for supply chain regulatory compliance requirements. For example, heavy paperwork, which used to be hallmark of most merchandising businesses, has made way for automation. Global supply chain regulatory compliance has to take factors such as these into consideration.

global-supply-chain-regulatory-complianceOther developments in allied areas such as intellectual property rights have gone on to strengthen the role of global supply chain regulatory compliance. As countries demand greater protection for their intellectual property products, they use global supply chain regulatory compliance as an instrument to enforce these, when these products concern exports.

In addition, there could also be other critically important issues in global supply chain regulatory compliance that may not be related to any of these, but can play a decisive role in disrupting global businesses. Think of natural disasters such as the Fukushima earthquake or the many natural disruptions such as hurricanes in South and North America. These could throw businesses out of gear. Global supply chain regulatory compliance is a kind of insulation against the uncertainties caused by events such as these.

In other words, global supply chain regulatory compliance should leave no stone unturned. There is no scope for compromise of any kind in implementing global supply chain regulatory compliance provisions.

Items that go into global supply chain regulatory complianceMeeting global supply chain regulatory compliance requirements means having to take care of a number of ingredients. Some of these are:

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Upcoming crucial global supply chain regulatory compliance regulation in the USSeveral legislations aimed at bringing about global supply chain regulatory compliance are in place. However, at this point of time, a really crucial global supply chain compliance regulation that could play a major role in the US in the coming years is the Automated Commercial Environment (ACE).

global-supply-chain-regulatory-complianceIn a nutshell, this U.S. Customs and Border Protection (CBP)-mandated regulation aims to bring in place a single portal which will make information on imported goods flow electronically from the businesses themselves right to the respective departments or agencies that require and handle them. The ACE is aimed at making import and export related work paperless, while also seeking to become a major facilitator of trade.

 

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Why Trade Compliance and Logistics Must Work Together

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Trade compliance and logistics must work together for a number of important reasons. While on the surface, trade compliance for logistics may seem burdensome for many organizations, the benefits of getting their trade compliance and logistics to work together are multifold and far outweigh the short term effort that goes into it, and that of noncompliance.

Undoubtedly, the most important reason for which trade compliance and logistics must work together is that they ensure that there is compliance with the laws of the countries into which the goods travel. It is a lot easier and a lot uncomplicated to have goods moving within national boundaries, where one can expect familiarity with the rules and the operating environment. In the case of global trade, the story is different.

Need to grapple with multiple laws

why-trade-compliance-and-logistics-must-work-togetherThere is great diversity and complexity of laws that govern trade compliance and logistics. They are now more integrated than at any point of time before because of the advent of new technologies. This brings in a motley mix of the elements of global business, such as currencies, laws, locations, people and so on. Businesses that have a stake in the global trade have to deal with these varieties and diffuse elements. One of the surest ways of ensuring that these are managed rightly is by getting trade compliance and logistics to work together.

Since there is a multitude of international laws that need to be complied with at many stages of the global supply chain; trade compliance and logistics must work together. This is the only sure way of ensuring that the company’s goods and products meet the required international trade guidelines and reach their destination safely.

A way out of the complexity

why-trade-compliance-and-logistics-must-work-togetherFor many in the business of exports, complying with the global supply chain may seem complex. However, knowledge of the laws of respective countries and building a sound logistics and supply chain infrastructure will go a long way in mitigating the problems associated with these. This is why trade compliance and logistics must work together.

Imagine a consignment of textiles originating somewhere in the Middle East headed for North America. This consignment has to pass through a few countries, at each of which it has to be sure it meets the compliance requirements. Finally, even when it reaches its destination, it must ensure that the laws of that country are complied with.

Increased efficiency and enhanced reputation 

why-trade-compliance-and-logistics-must-work-togetherAnother important reason for which trade compliance and logistics must work together is that there are substantial long term gains to be had by doing so. Supply chains that have come about as a result of trade compliance and logistics working together become more reliable and efficient. All these mean reduced costs in the long run, increased customer satisfaction, and enhanced reputation in the business.

Elaborating on the point above, it is also equally true that trade compliance and logistics must work together to pump up nations’ economic growth. A country that ensures that trade and logistics are in accordance with internationally legislated laws on the subject are more likely to be trusted by global businesses. Countries in which trade compliance and logistics work together and result in sound business infrastructure are naturally more preferred by businesses as transit routes or destinations for their products. This brings in substantial revenues to the countries.

 

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