The new pharmaceutical enterprise business model requires dramatic changes in drug discovery, clinical research, and clinical and commercial manufacturing.
The business and regulatory environment in the pharmaceutical industry is changing rapidly and this pharmaceutical company recognized the need to define their new business model and strategic execution plan. The new risk based regulatory approach to enforcement of current Good Manufacturing Practices is increasing the need for a well documented approach to compliance. New bio-medical technology and socio-political price and delivery pressures are changing pricing structures, product portfolio mixes, and shortening commercial product life cycles. Delivering exemplary customer supply and service is an opportunity to gain customers, but a challenge to execute.
The client recognized they needed external viewpoint from an independent third party with deep understanding of both the Pharmaceutical industry and manufacturing systems. ARC collaborated with members of the client's team to develop their Integrated Technology Plan. The deliverables included a report defining their vision of the future for pharmaceutical manufacturing plant (5-7 years). The breadth of manufacturing operations addressed extended from the receiving dock to finished product including factory floor automation. The tasks involved on-site plant audits, interviews with key personnel, interviews and research from other leading manufacturing and supplier companies.
The Pharmaceutical factory of the future was defined including a systems architecture that is both flexible, scalable and affordable. Both leveraging industry standards and some internal standardization were incorporated. This strategic document is driving their capital budgets for their plants worldwide. The company is keeping their operations in-line with current and future plans involving automation, technology and best practices. There was consideration of outsourcing large portions of manufacturing, but the strategy gave the senior executive team the confidence and influence to keep manufacturing domestically.