Gaëlle Jaron leads the digital services business of Rephine, including Rephine Catena™, its new end-to-end digital global pharma supply chain quality management solution. Rephine Ltd is a firm of deeply experienced GMP auditors which proactively help pharmaceutical companies around the world with their supply-chain quality assurance.

Gaëlle Jaron

Pharmaceutical products require end-to-end quality assurance or they can’t be distributed, so it is somewhat surprising that the entire supply chain does not undergo more rigorous, systemized scrutiny.

Food, however, is a global industry that has learned the importance of 360° supply-chain vigilance, as contamination issues and other scandals have put companies under sometimes unwelcome scrutiny. In consequence, in recent years, most major food retailers have digitalized their supply chain quality management and monitoring, to mitigate the risk of standards shortfalls.

Quality and safety are every bit as crucial for pharma, and a big part of maintaining quality is ensuring that standards are upheld throughout the supply chain. But the manual processes that are still being used by the majority of pharma organizations are fraught with risk, while their labor intensity can result in high annual costs even for smaller firms.

Digitalizing end-to-end supply chain quality monitoring and reporting offers several major advantages. Below are some insights into what has been achieved across the food industry, through digitalization of supply chain quality monitoring, based on UK-based case studies from a Rephine partner. These examples may offer some ideas for equivalent transformations in pharmaceuticals.

British firm Oddbox, which delivers fruit and vegetable boxes, was undergoing a period of rapid growth and needed to be able to monitor risk across its whole supply chain. It has now mapped its supply chain digitally, and streamlined claim and supplier audit-management to create a single view of quality issues. This should mean it can continue to grow without worrying about standards falling.

Most pharma organizations are looking for greater visibility and control, especially when they undergo periods of growth and change. Digitalization could help to boost clarity and order as converging supply chains are streamlined.

Waitrose, the UK supermarket chain, introduced a Responsible Efficient Production Index, to highlight and foster best practice across its fresh produce supply chain.

It digitized performance assessment at a farm level based on a scoring system of assessments, and set up centralized communications with individual farms to promote continuous improvement. The retailer now benefits from more consistent data collection across its farms; insights into the relative strengths and weaknesses in the supply chain; and faster feedback/responsiveness.

Waitrose’s enhanced ability to share best practice could act as a model for pharma, given that supply-chain transparency is encouraged by many regulators.

UK recipe box delivery brand Hello Fresh was suffering from unstructured supplier data, which made it difficult to assess compliance. It also wanted an easier way to follow up with key suppliers about quality on a regular basis.

The company digitized its remote supplier auditing and assessment, supply-chain mapping and specifications management, with KPI tracking across all suppliers. Today it can access and react to real-time data, and the improved visibility and sense of control should allow it to develop further sustainability initiatives.

Pharma organizations could apply similar digital mapping to the different components of the supply chain of a marketed drug product and track these more continuously.

The Big Table Group operates the restaurant brands Las Iguana, Bella Italia and Café Rouge. The firm needed to restore growth and capitalize on post-pandemic demand but lacked visibility down the length of its supply chain.

The firm undertook digital mapping, which identified 900 additional/previously invisible suppliers. Quality assurance data is now managed digitally and a digital risk scoring system heightens accuracy, covering 

the company’ssuppliers. The company also now captures supplier documentation digitally, such as policies on modern slavery, animal welfare, food safety, etc.

As well as improving risk mitigation across the end-to-end supply chain, The Big Table Group has been able to streamline new supplier approvals and demonstrate responsible operations.

Risk management in pharma is still managed mostly manually, using spreadsheets, but in the future, organizations will be expected to monitor

 their suppliers, not just key players, and to do this continuously and in real time, rather than via a one-time ‘snapshot’ every 2-3 years.

UK supermarket chain Tesco receives its milk supplies directly from a group of 600 dairy farmers known as The Tesco Sustainable Dairy Group (TSDG). To fulfil Tesco’s strict quality criteria, the firm needed to demonstrate performance against a quarterly scoring system covering issues such as the health and welfare of herds.

Tesco’s priorities were to digitize real-time data capture from farmers, and to monitor key aspects of the scoring system. Now that it has access to detailed supply chain quality data, Tesco can identify and reward its top 5% of farmers and target its under-performing farms with tailored action plans, almost in real time. It also has facts to support any claims about the quality and provenance of its dairy products.

The pharma industry is assigning increased value and prominence to corporate social responsibility and carbon reduction, and as it does so, it too needs to have evidence to back up its claims.

UK pork producer Karro wanted to accelerate the supplier/farm approval process. As well as critical documentation capture, Karro has digitized its questionnaires and risk assessments for supplier selection and lifecycle management, and on-site audits to assess site security, animal welfare, transportation management etc.

The accuracy of its farm and supplier data now enables Karro to benchmark its suppliers and view on-demand insights about performance improvements.

The pharmaceutical industry could benefit from a similar focus on quality at every level—for instance, ensuring that GMP standards are met for 

 materials, packaging and services used in medicines.

Winterbotham Darby is Britain’s leading supplier of chilled Mediterranean and plant-based foods to the retail, food service and B2B sectors. It works with over 800 suppliers, and requires transparency right along the supply chain—from farmer and grower to manufacturing and primary processing.

The company is now centrally capturing critical information about everything from the use of antibiotics and pesticides to water usage and animal welfare—data that it can share with customers and which allows it to deliver on agreed strategies, supported by factual evidence, which in turn boosts customer confidence.

Pharma, on the other hand, still has a long way to go to confidently capture and evaluate its supplier data, but that also gives it the opportunity to move straight to best practice—learning from the experiences of the food sector.

The transformations seen in the food industry show the extent to which smarter supply chain quality management can be a competitive advantage.

And if the start and end points are clear, driving the transformation needn’t be onerous. Pharmaceutical organizations should set up a multi-disciplinary taskforce, which should include representatives from Quality, Procurement and IT, a Supply Chain representative if possible, and someone from Regulatory.

However, just selecting an electronic quality management system (QMS) will not implement change by itself. Real 

requires a detailed understanding of the global corporate picture. Plus, any new capability must be able to exchange data with existing legacy systems.

There is already strong demand for greater supply chain transparency: over the next 2-3 years, such expectations will only increase—and in many cases, become mandatory. Procrastinating about transformation is not an option—tomorrow will be here sooner than you think.

Gaëlle Jaron leads the digital services business of 

Articles

Pharma compliance requires stringent quality assurance in order to ensure patient safety, but the default for many pharma companies is still to use manual processes for supplier vetting and reporting. Gaëlle Jaron looks at how the food industry might inspire pharma to transform its processes