Pharma 4.0™

ISPE and its members are developing the roadmap to introduce Industry 4.0, also referred to as the Smart Factory, to the pharmaceutical industry as Pharma 4.0™.

Mission Statement

The aim is to provide practical guidance, embedding regulatory best practices, to accelerate Pharma 4.0™ transformations. The objective is to enable organizations involved in the pharmaceutical product lifecycle to leverage the full potential of digitalization to provide faster therapeutic innovations and improved production processes for the benefit of patients.
Implementing new Industry 4.0-based manufacturing concepts in Pharma 4.0™ requires alignment of expectations, definitions, and interpretation, with global pharmaceutical regulations.
While Industry 4.0 has been called a new industrial revolution, Pharma 4.0™ implementation will more likely resemble an evolution in which digitalization and automation meet very complex product portfolios and cycles. It is therefore important to achieve an accepted understanding of readiness and maturity, starting with additional digital enablers and elements added to the ICH Q10: The Pharmaceutical Quality System along the product life cycle. It is also important to develop business cases to showcase which Industry 4.0 automation and digitalization technologies can be applied to the pharmaceutical industry and what implications are faced due to the increasingly complex regulatory challenges in the pharmaceutical and biotechnology industries.
Digitalization, an important component of Pharma 4.0™, will connect everything, creating new levels of transparency and adaptivity for a “smart” plant floor. This will enable faster decision-making, and provide in-line and on-time control over business, operations, quality, and regulatory compliance. Notably, this new connectedness will require higher levels of security, since linked systems heighten vulnerability.
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