Validation 4.0

Validation 4.0



As Pharma 4.0 increasingly becomes reality, our validation practices must change.  We can no longer apply 20th-century thinking to 21st-century technology and resources.  Validation must adapt to industry shifts from iterative to disruptive innovation, from batch to continuous processing, from bulk processing to personalized medicine, from centralized systems to the Internet of Things (loT), from controlled data to distributed data and similar changes.


What does validation in the context of Pharma 4.0 - i.e., "Validation 4.0" - look like, and why do we as validation professionals care?  Just as validation practices and paradigms shifted throughout the industry's prior evolution, so must they change to keep pace with future evolution.  Adoption of quality risk management (QRM) and quality by design (QbD) principles and practices in validation lagged behind industry adoption.  Unless we prepare now, the adoption of validation practices for Pharma 4.0  innovations will lag behind industry adoption, and this could jeopardize implementation of industry innovations.  This challenge applies to all validation, not only computer system validation.


Validation concepts have developed and evolved as the industry has tried to adopt new trends and technologies.  However, in Pharma 4.0 we must integrate these concepts; therefore, it is now the time to rethink the validation strategy and facilitate the move to agile processes.  The validation strategy must be part of the holistic control strategy, and stakeholders must use critical thinking to ensure lean and robust risk assessment.

This transition in validation strategies is facilitated by adopting QRM-based integrated commissioning and qualification principles defined by the revised ISPE Baseline Guide, volumes; risk­based process performance qualification, as defined in the Good Practice Guide for Practical Implementation of the Lifecycle Approach to Process Validation; and the risk-based approach to computer system validation defined in the GAMP-5 Guide.  Together, these efforts can potentially help shift validation paradigms to make Validation 4.0 a reality.


Current practices lead to silos between computer system validation, facility and equipment qualification, product and process qualification, and the overall quality systems.  These silos inhibit innovation within the industry.  This is not just a business concern - it is also a risk to the delivery of lifesaving therapies to the patients served by the industry.   The goal of Validation 4.0 is to develop a cohesive, harmonized, integrated, holistic, risk-based approach for process performance qualification incorporating computer system validation that builds on the Pharma 4.0 operating model and includes the holistic control strategy, digital maturity, and data integrity by design.  This approach will help support and facilitate current and future innovations in the pharmaceutical industry.

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