Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
News|Articles|September 9, 2026
Why Oral Solid Dosage Validation Is a Business Continuity Function, Not Just a Compliance Requirement
Author(s)Sri Harsha Chakrapani
In commercial tablet or capsule operations, validation helps protect the site’s ability to produce, release, and supply product without repeated disruption. This article discusses validation as a technical control system that supports manufacturing continuity.
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Organizations sometimes treat validation as a document trail that follows manufacturing. In oral solid dosage (OSD) operations, that view is too narrow. A batch record, protocol, or report may be the visible artifact, but the real purpose of validation is to show that the process is understood, controlled, and capable of routine performance within a defined operating space.
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