The Pharma 4.0 Future Desired State is to be data-driven & capable of holistic process control with information available at the right time with content, quality, security and traceability. This Digital Maturity ensures patient safety & intended product performance. To get to this state, Pharma 4.0 defines enabling capabilities for systems in general, and connectivity in particular, to achieve vendor-agnostic “Plug and Produce”. This presentation covers the status and progress made in the Pharma 4.0 Plug & Produce workgroup on architecture, connectivity standards, current proof of concept projects and insights from Hackathons, including realized concept of a simplified vendor-agnostic integration of qualified laboratory devices with the Asset Administration Shell as the Digital Twin. Links to relevant ISPE publications, including new Pharma 4.0 concept papers, are provided. Bridging strategies for brown-field equipment and collaborations with other industry working groups e.g., NAMUR, BioPhorum Group, VdMA, SiLA, LADS are touched on as well.
Head of MSci Innovation,
Takeda Pharmaceutical International AG