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Pharma 4.0 is a comprehensive operating model for pharmaceutical firms that incorporates an advanced production control approach. It is focused on Industry 4.0 which is the next step toward smart manufacturing.

Pharma 4.0 is the digitized operations model of a pharmaceutical organization that consists of trends such as,

1.Big data,
2.Inter connectivity
3.Collaborative Robotics
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

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