In today’s pharmaceutical environment, regulatory success is no longer determined by whether guidelines were followed, but by whether decisions can withstand scrutiny months or years after they were made. The Science of Pharmaceutical Manufacturing – Book 2: From Compliance to Capability was written because modern failures are no longer forgiven, explained away, or quietly corrected; they are dissected, challenged, and judged across inspections, stability drift, post-approval changes, bioequivalence failures, and global submissions. Organizations increasingly discover that being compliant is not enough when they cannot explain why impurity limits were chosen, why risks were accepted, why controls will remain stable under drift, why dissolution predicts bioequivalence, or why changes will not destabilize products. Regulators no longer ask what was done, but why it should be trusted. This book addresses where products truly fail, through unmanaged nitrosamine risk, late extractables and leachables responses, underestimated moisture interactions, post-approval solid-state shifts, fragile stability strategies, and repeated bioequivalence collapse caused by missing performance logic. It explains why dossiers fail when they are written to submit rather than survive, why specifications lack scientific backbone, why declared design spaces are not defensible, and why weak reasoning is rejected even when data appears complete. It exposes how modern inspections test decision logic, root-cause depth, change maturity, and data-intelligence rather than basic compliance, and why traditional static risk management is obsolete in systems driven by trends, human behavior, and lifecycle drift. Introducing a dynamic, predictive, and integrated QRM framework, this volume shifts organizations from reactive compliance to sustainable capability. Written for formulation leaders, quality heads, regulatory professionals, development scientists, and senior decision-makers, this book defines the architecture of prevention, proof, and regulatory trust, serving not as a reference manual, but as a decision-defense system for long-term pharmaceutical survival.