Good Practice Guide: Validation 4.0
Published: June 2025
Pages: 152
The Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient safety throughout a pharmaceutical product's lifecycle. A Holistic Control Strategy (HCS) in this context means moving beyond traditional, static, upfront and localized validation controls to a dynamic, data-driven, and continuous approach to managing risks and quality along the broader value chain.
This Guide is intended to be an early introduction into modern validation thinking in an increasingly digital world that offers new capabilities for managing and controlling manufacturing processes. The structure starts with an overview of methodology considerations, covers foundational enablers, required capabilities and a section on real-life case studies that have been selected to explain aspects to consider when adopting Validation 4.0 in practice.
A Maturity Self-Assessment Tool is included in the E-Reader (under Materials/Supplements) as a downloadable Microsoft® Excel® file to purchasers of the Guide. See the FAQ for accessing instructions.
The primary intention behind this self-assessment tool is to empower organizations to accurately characterize their current state of maturity and, more importantly, identify specific areas where targeted improvements can be made.
Guide Core Team
For the full list of contributors to this Guide see Guidance Document Teams