In this article, Ben offers pharma company procurement teams three top tips to finding a trusted consumables supplier to ensure the security and integrity of their supply chain. The author offers advice on questions to ask suppliers, including suppliers of single-use manufacturing equipment, to ensure that they are satisfied that their partners can continue to deliver material when they need it. The author highlights the steps ChargePoint Technology has taken to ensure that they remain a reliable and trusted partner even during these unprecedented times.
For the pharmaceutical industry, managing supply chain risk has never been a higher priority. This is particularly true when it comes to ensuring a reliable supply of consumables - whether ingredients for drug formulation, materials for device and packaging manufacture, or for single-use technology (SUT) for production lines.
The COVID-19 pandemic revealed critical gaps in consumables supply chains and created anxiety as managers scrambled to assure continuity. Learning from the last 24 months is critical if we are to ensure the pharmaceutical supply chain is more resilient and reliable in future.
In this article Ben Wylie, Snr Product Manager at ChargePoint Technology will explore these issues, providing his view on how risk-based approaches to purchasing/specifying consumables relative to product, process and supplier can help de-risk this critical supply chain and help drug programme managers sleep better at night.
The pharmaceutical industry has undergone considerable upheaval over the last two years due to the COVID-19 pandemic, exposing previously unknown vulnerabilities that need to be addressed.
At the height of the first wave of COVID-19 cases in spring 2020, a number of developments caused disruption in the industry. The closure of factories and export restrictions introduced from countries which produce significant portions of the world’s active pharmaceutical ingredients (APIs) and excipients, caused considerable disruption to drug manufacturers across the globe.
In addition, measures designed to control travel to minimise inter-country transmission, combined with a rapid rise in cases in the global freight sector, posed challenges to companies. They resulted in an interruption of essential transport of ingredients, raw materials, as well as consumable production line equipment across the globe. This led to a significant increase in lead times for the supply of essential consumables that impacted on manufacturing productivity, leading to delays in the delivery of vital medicines around the world.
While the events of 2020 demonstrated weaknesses across pharmaceutical supply chains, they also showed that some segments are more susceptible than others. One such is the highly potent active pharmaceutical ingredient (HPAPI) sector, and not simply because of issues sourcing HPAPIs or their ingredients.
HPAPIs, due to their potent nature, require specialist manufacturing processes and production line equipment. This is vital to minimise the risk of operating staff being exposed to hazardous compounds and to prevent crosscontamination between compounds.
Many HPAPI processing lines make use of SUT transfer components, such as single-use Split Butterfly Valves (SBVs) and chargebags, to ensure optimum containment. These offer particular advantages to manufacturers, as they minimise cleaning and washdown requirements, making it possible to minimise contamination risk while enhancing production line efficiency.
The pandemic showed that to ensure a stable and reliable supply of these single-use components during future economic uncertainty, suppliers and pharmaceutical companies need to have effective contingency plans in place to secure their supply chain.
Sterile processing lines are similarly exposed. Manufacturers need to maintain suitable cleanroom environments when processing sterile products, such as parenteral drugs, while also maximising line productivity. To achieve this, many make use of specialist aseptic SBVs and other SUTs due to their combination of optimum aseptic integrity and reduced cleaning and validation requirements.
As with HPAPIs, it is imperative that they are able to source their equipment from reliable suppliers with their own robust supply chains to safeguard against any unforeseen disruption to international trade.
While there seems to be light at the end of the tunnel with regards to COVID-19, the related economic uncertainty continues, with implications for the pharmaceutical supply chain. As more countries open up, we are seeing demand outstripping supply in the pharmaceutical sector and in other industries, leading to rising prices and extended lead times on new orders of consumables of all stripes.
Conflicts are also leading to a rise in energy and commodity prices, which may well have a knock-on effect for manufacturing productivity within the pharmaceutical industry, as well as on global supply chains.
It is no surprise then that many companies across the pharmaceutical industry have taken steps to rethink their consumables supply chains. Not just consumables suppliers, but drug developers and contract development and manufacturing organisations (CDMOs) are exploring how to de-risk in order to further enhance the reliability and quality of the support they provide their customers in the future.
The work of SUT manufacturers to mitigate against supply issues during the first wave of COVID-19 offers a number of important lessons for the rest of the industry as it looks to build a more resilient consumables supply chain capable of handling ongoing uncertainty.
The steps to enhancing the robustness of their consumables supply:
A standard pre-COVID-19 supply chain features a number of weak points that can act as a single point of failure. The industry’s reliance on a single global region for much of its API supply, for example, made it vulnerable when factories in that part of the world paused operations due to COVID lockdowns. This is one reason why some national governments have tried to encourage companies to onshore their supplies.
As discussed earlier, a heavy reliance on JIT delivery for many commodities also posed an issue when transport networks were disrupted.
Relying on a single company for an essential supply is also a potential liability highlighted during pandemic. If the company fails and ceases operations, then that can cause considerable delays.
To build a more resilient supply chain in the future, it is important for companies to identify such single points of failure in their own operations, as well as the risk of failure, so they can take steps to address them.
As shown by the experience of many SUT manufacturers, having a ready supply of raw materials or essential components can help mitigate the impact of any delays in new deliveries, enabling them to continue manufacturing and supply customers.
With this in mind, it is recommended to take steps to build an inventory of any essential ingredients or consumable equipment, and explore ways of expanding Where companies are supplying markets overseas, it may be advisable to explore ways of building stocks of finished goods within those markets to ensure they can deliver even when there are international shipping delays.
Seeking more than one supplier for essential goods, and working with partners from across the globe can help address the single points of failure identified during the first step. Working with only local partners is not an option for some essential materials or SUTs, as they may not be produced domestically. Nor is it always desirable — it is possible a local market may experience supply shortages.
Creating a global network can ensure access to all of the high-quality consumables as and when they are needed. Multi- or dual-sourcing can also help to enhance the flexibility of supply, helping businesses to respond more rapidly to issues with individual partners.
Finally, it is crucial to seek out and work with partners that are reliable and have the capacity to support manufacturers in achieving their supply chain security goals.
It is advisable to work with consumables suppliers that have, themselves, taken steps to enhance the robustness of their supply chains, whether through diversification, the introduction of multisourcing or the building up of stock. Asking potential partners about their own supply chains, and about their global operating footprint, can help manufacturers understand whether they will be able to complement and boost their own efforts.
Working with suppliers that have a global operating footprint, with sites and operations in multiple countries, can also optimise the robustness of supply chains, as they will be less vulnerable to localised or regional supply challenges.
It is important to work with partners that have a reputation for reliability and quality. They must be able to offer you a consistent service and deliver the highest standard materials and components to help you ensure you can operate consistently.
In addition, it is important to seek out suppliers that you can be confident will continue to operate for the long term. Exploring suppliers’ financial health before making any agreement can help give you the peace of mind that they can be relied on for the long haul.
With these frailties in mind, rapid action has been needed on the part of SUT suppliers to safeguard their customers.
During the first wave of COVID-19 in particular, many suppliers of SUTs took steps to minimise their exposure to potential points of failure, such as just-in-time (JIT) deliveries. Maintaining adequate levels of essential raw materials, and building stocks of finished components within key overseas markets, have been important ways of addressing this issue. It ensured that manufacturers could continue to manufacture their components and deliver them to customers without disruption.
Another step taken by SUT manufacturers has been to try to expand their footprint beyond their core markets, establishing new sites within their customers’ geographies. Given that countries such as the US and India have been incentivising their domestic pharmaceutical sectors to localise or “onshore” their supply chains, establishing local sites can help SUT manufacturers address customers’ concerns about relying on imports.
SUT manufacturers have also begun reconsidering their own supply chains to optimise their resilience, and to support customers in achieving the same goal. Diversifying their network of suppliers beyond individual companies
or single regions is an important way of preventing the creation of single points of failure, so they can continue to supply customers.
Dual- or multi-sourcing is also another key measure taken by a growing number of SUT and other consumables manufacturers. Multi-sourcing describes a supply planning system that can intelligently choose between alternate sources of supply. While not without its own complexities and challenges, this approach has the potential to allow SUT manufacturers to respond in real time to disruption, enabling them to switch from an affected supplier to one that is able to continue to deliver.
While the economic turmoil from COVID-19 looks to be settling down in many parts of the world, there are other developments that have the potential to pose challenges for the global economy, and for the pharmaceutical industry in 2022 and beyond.
It is important for pharmaceutical companies to prepare now to ensure their essential supplies, not just of raw materials, but of SUTs and other key components, are secure and sourced from reliable partners so that they can continue to operate.
Pharma companies don’t need to take responsibility for this preparation entirely on their own shoulders — they should work with suppliers that are doing the same and securing their own networks. Such suppliers create resilience further down the supply chain, helping to support the wider pharmaceutical industry in creating a more robust, secure and certain future.
More for information, please visit Product Filtering | Powder Transfer Systems | ChargePoint (thechargepoint.com).
BEN WYLIE is the Senior Product Manager at ChargePoint. He joined ChargePoint in 2005 and is responsible for the day-to-day and strategic management of the product portfolio, including the development of the ChargePoint single-use solutions. Ben has 14 years of experience in Pharma with a focus on marketing and product management of powder processing and containment handling
