Innovations at INTERPHEX Guide 2022 - 12

Quality Control and Pharma 4.0
Transitioning to Automated Testing, Online Monitoring, and Digitization
Kaitlyn Vap and Hayden Skalski, Sievers Analytical Instruments
Introduction
For pharmaceutical quality control (QC) testing,
transitioning to Pharma 4.0 represents a disruption to
traditional approaches and a move to automation, realtime
testing (RTT) / real-time release testing (RTRT), and
adoption of Process Analytical Technology (PAT). This
transition applies to the analysis of both product and
process parameters, including routine product testing,
pharmaceutical-grade water monitoring, testing of
raw materials and active pharmaceutical ingredients,
and ongoing process verification and control, such
as in cleaning validation. A crucial component of this
evolution is digitization in addition to automation. Not
only do digitization and automation have the potential
to revolutionize efficiency in QC, but they can also
improve quality and compliance with fewer human
errors and less variability.

Innovations at INTERPHEX Guide 2022

Table of Contents for the Digital Edition of Innovations at INTERPHEX Guide 2022

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