Features
July / August 2020

Achieving Vertical & Horizontal Integration in Pharma 4.0™

Teresa Minero
Alberto Augeri
Achieving Vertical & Horizontal Integration in Pharma 4.0™

Recent projects on serialization and track and trace help illustrate the concepts of vertical and horizontal integration. With vertical integration, the unique product identification information (serial number, lot, etc.) used by sensors and printers on the packaging lines is made accessible to the supply chain and regulatory hubs throughout the entire technology stack. With horizontal integration, which employs heterogeneous systems and technologies, a single physical pack of medicines moves through the supply chain accompanied by the correct information about its state and characteristics, right up to delivery to the pharmacist and, ultimately, the patient.

This is the third in an ongoing series of articles about Pharma 4.0™. In the Pharma 4.0™ revolution, information is an integral part of the final pharmacological product. A cornerstone for generating this information is the extent, and successful application, of simultaneous, mutual interaction between vertical and horizontal integration.

Integration itself is not a novelty. Vertical integration has been connoting industrial system architectures since the 3.0 revolution of the 1970s and 1980s, which was primarily aimed at supporting production and logistic operations and related to automation and IT production. Horizontal integration has also been used for years in the logistic procurement cycle, with dedicated channels between partners as well as business-to-business platforms. Now, in light of the technological, conceptual, and process-related opportunities offered by Pharma 4.0™, the potential of integration in the pharma industry is a promising avenue for investigation.

Pharma 4.0™ logo

Integration’s Potential in Pharma

Let’s review aspects of this potential, starting with vertical integration. In its current state, vertical integration makes collecting data from the field simpler (and therefore quicker), less expensive, and more comprehensive than in the past. We can use 3.0 vertical integration methods, such as supporting operations through alarm detection, gaining printouts of process values to be attached to batch reports, and making quick interventions to the machinery. Additionally, we can rely on effective big data collection and treatment to automatically compile batch reports, manage events by exception, join and combine production and quality control results, reduce errors in manual data handling, and assist quality assurance revision and approval processes, ultimately reducing each batch’s time to market. To strive even further, with continuous verification toward a well-defined golden batch, we can achieve a deeper understanding of both known and hidden process dynamics, event-based predictive maintenance, and eventual optimization of both operations and investments.

This movement is not just about serialization.

A practical example derives from the increasingly successful application of the concept of digital twins in the equipment control systems in a plant. The entire data and configuration set is replicated by integration in an appropriately configured digital twin. Subsequently, the continuous acquisition of parameters, process values, events, and external actions in all phases of equipment operations, along with intelligent, appropriate elaboration in near-real-time, provides a complete set of information that remains available for several different uses, such as overall equipment effectiveness analysis, consumption analysis, product quality review, and the value-added effects described previously. Furthermore, because the initiative engages a wide range of personnel, with a variety of professional skills and potentials, it inherently implements new awareness, participation, and quality in the work-place.

Let’s continue with horizontal integration. Full integration between the contract manufacturer and marketing authorization holder is an old dream, unrealized or not fully implemented due to high costs, the need for heavy infrastructure, and concerns about data security, confidentiality, and even validation. Serialization seems to indicate the path to light infrastructure, ensured confidentiality, and security with fully effective information exchanges in the operational cycle, in a validated environment. The old dream seems much closer to becoming reality, along with a wider supply chain visibility, which appears to be increasingly important in mid- to long-term market perspectives. The sooner the dream comes true, the better off all stakeholder in pharma will be.

Should we remark on the effects of the ever-pursued short circuit between the research and development pipeline and punctual information on medicine usage? Or on the feedback made accessible by therapeutic adherence, with its implications in terms of service brought to the patient? Perhaps it is enough to cite the significant movement toward a structural exchange of information that local and global regulations are increasingly develop-ing—this movement is not just about serialization but also, to mention a few other innovations, unique device identification (UDI), eXtended EudraVigi-lance Medicinal Product Report Message (XEVPRM) and Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) (for drug safety), and identification of medicinal products (IDMP).

Conclusion

When conceived in the way proposed in this article, the integration process opens the door to new information robustness and transparency, which are certainly explicit, growing requests by regulators. Additionally, integration in Pharma 4.0™ promises to substantially improve development, production, and logistic operations, with advantages for all stakeholders: the industry in all its components, regulatory authorities, and patients.

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