Verification and Validation of Computational Models Used in Biopharmaceutical Manufacturing: Potential Application of the ASME Verification and Validation 40 Standard and FDA Proposed AI/ML Model Life Cycle Management Framework

Abstract

A wide variety of computational models covering statistical, mechanistic, and machine learning (locked and adaptive) methods are explored for use in biopharmaceutical manufacturing. Limited discussion exists on how to establish the credibility of a computational model for application in biopharmaceutical manufacturing. In this work, we tried to use the American Society of Mechanical Engineers (ASME) Verification and Validation 40 (V&V 40) standard and FDA proposed AI/ML model life cycle management framework for Software as a Medical Device (SaMD) in biopharmaceutical manufacturing use cases, by applying to a set of curated hypothetical examples. We discussed the need for standardized frameworks to facilitate consistent decision making to enable efficient adoption of computational models in biopharmaceutical manufacturing and alignment of existing good practices with existing frameworks. In the study of our examples, we anticipate existing frameworks like V&V 40 can be adopted.

Keywords: Biopharmaceutical manufacturing; Computational models; Digital twins; GMLP; Machine learning; Verification and validation.