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 (IoT), from controlled data to distributed data, and similar changes.
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.
The 20th century was the era of block buster pharmaceuticals, during which the pharmaceutical industry unsurprisingly adopted the principles of mass production. As we enter the era of product differentiation and personalized medicine, we should learn from other industries that started this journey before us.
There are three key external enablers and trends for a new Pharma 4.0™ approach to validation:
Regulatory encouragement to help the pharmaceutical manufacturing sector mature to a maximally efficient, agile, and flexible state, in which manufacturers reliably produce high-quality drugs without extensive regulatory oversight (21st-century GMP initiative)
Advancement of health sciences knowledge to the molecular level, enabling the pharmaceutical industry to evolve from “discovering” medicines to “engineering” the next generation of differentiated, competitive medicines
Innovative technologies that are smarter and more adaptive in conjunction with software capabilities to handle large amounts of adaptive, self-optimizing data in near real time
The holistic control strategy will facilitate the delivery of process performance qualification and incorporate a range of innovative technologies.
Validation will be built in, and the various groups involved in validation will have to work together. A siloed approach between CSV, facility and equipment qualification, product and process qualification, and the overall quality systems will no longer work.
“It is now the time to rethink the validation strategy and facilitate the move to agile processes”.
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 integrityby design.
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Reference: Industry Perspective: Validation 4.0 – Shifting Paradigms (C. Bennett, H. H. S. Horneborg Gilad Langer, L. Lundsberg-Nielsen, A. J. Margetts,.D. Fritz Röde)