By Daniel Matlis, president, Axendia
Two decades ago, most life sciences companies were vertically integrated. Raw material came in one end of the operation, and finished goods went out the other.
Around that time, industry and regulators began to collaborate to change the pharma manufacturing paradigm from “testing quality out” to “building quality in.” This resulted in approaches such as process analytical technology (PAT) and quality by design (QbD), which drove industry to gain a deeper understanding of product characteristics and manufacturing processes to allow for tight controls over critical-to-quality parameters.
Around the same time, life sciences companies began experimenting with outsourcing. Today, outsourcing is common, but has an unintended consequence — many brand owners have lost the ability to collect and capitalize on critical-to-quality parameters stored at an external facility. This data is not only needed to improve productivity, quality, and reliability, but also can have a significant effect on product safety and efficacy as well as innovation and regulatory compliance.
Globalization and outsourcing are here to stay. However, increases in outsourcing and globalization do not translate to a loss of visibility or responsibility.
A key challenge is that, today, visibility into the outsourced supply chain is primarily based on snapshots in time with little sharing of common practices and information. Our research shows that 77% of organizations rely on periodic audits as the primary method to gain visibility into suppliers. Yet surprisingly, only 25% of organizations share common practices and information with suppliers, and only 3% have access to suppliers’ data in real time.
Improving Outcomes with On-Demand Visibility
To address these challenges, brand owners must implement strategies to provide on-demand visibility across every stakeholder in their supply network. On-demand-visibility would ensure that organizations could actually get the information they need in order to support full genealogy and traceability across the supply chain. A key component to this is the willingness of partners to share information. In an age when outsourcers are outsourcing, the chain gets longer and even more difficult to assess. As a result, brand owners need to treat outsourced organizations as an extension of their quality systems, so they maintain consistent standards across all sites. To achieve control outside the corporate walls, brand owners should deploy processes and systems that enable them to connect the dots and bridge the gaps, regardless of who made a component or ingredient, or where it was made.
A key business practice is for brand owners to require suppliers and partners to provide a complete batch-history record for the raw materials/components being delivered, instead of a certificate representing a snapshot in time. Batch records provide visibility into critical-to-quality parameters, facilitating the ability to adjust downstream processes.
To support this level of transparency, brand owners and their supply networks should collaborate to integrate rigid command and control systems (e.g. ERP [enterprise resource planning], QMS [quality management system]) with Web portals and cloudbased supply chain intelligence infrastructures. This approach would allow life sciences stakeholders to be able to take full advantage of tools such as scorecards, dashboards, and event management approaches to support global supply chain optimization, transparency, and control.
On-demand visibility strategies provide the ability to obtain relevant information about the life sciences product at the appropriate time to enable decisions with a high degree of confidence based on the analysis of contemporary data. This approach would provide brand owners the opportunity to improve quality and manage costs by enabling process optimization and adjustment of critical-to-quality in-process parameters within a design space. Maintaining on-demand visibility of upstream processes (whether internal or outsourced, local or global) allows downstream control strategies to take into account the actual characteristics of raw materials, ingredients, and components. This approach would support improved productivity, quality, and reliability, as well as foster innovation and facilitate regulatory compliance.