Pharma 4.0 is the digitized operations model of a pharmaceutical organization that consists of trends such as,
4. Artificial Intelligence (AI)
5. Distributed cloud-based architectures
The ISPE Pharma 4.0 Special Interest Group (SIG) was formed with the aim of developing a working model for applying Pharma 4.0 principles.
In the operational model, the submitting methods and production controls are combined to construct a prescription quality mechanism covering the whole product life cycle.
Industry 4.0 + ICH Guidelines = Pharma 4.0 Operating Model