E-Book | May 30, 2024

Effective Process Validation Accelerates Your Drug To Market

Source: Mycenax

By Viola Wu and Albert Liao, Mycenax

Bioreactor-GettyImages-801080522

Traditional process validation typically relies on demonstrating successful commercial-scale batches before regulatory submissions. While still employed, a more comprehensive strategy has emerged, calling for more life-cycle-oriented considerations. Process performance qualification (PPQ) is now established throughout the entire product life cycle, complemented by continuous process verification (CPV).

Conventional validation remains relevant, but as a component of the broader PPQ. PPQ, alongside CPV, incorporates a holistic view of process performance. This framework builds on Quality by Design (QbD) principles, emphasizing risk-based controls, leveraging lifecycle knowledge, and fostering continuous improvement. These elements now serve as guiding principles for ensuring consistent process performance.

Biologics manufacturing process validation aims to demonstrate consistent quality product delivery. It involves identifying critical process variables and establishing control strategies to maintain them within acceptable ranges.

As knowledge and experience in biologics manufacturing have grown, regulatory expectations and industry practices concerning process validation have evolved. Today, a successful program requires not only periodic PPQs but also ongoing CPV throughout the product lifecycle. Discover how building a product development program with a long-term vision and adopting a holistic PPQ and CPV strategy from the outset are now crucial.

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