This section establishes the regulatory and scientific foundation of process validation aligned with U.S. Food and Drug Administration process validation guidance and International Council for Harmonisation principles. It defines validation as a lifecycle activity and introduces the requirement to maintain traceability between process knowledge, control strategy, and ongoing verification.
Process validation is the collection and evaluation of data from process design through commercial production that establishes scientific evidence that a manufacturing process can consistently deliver quality product. It is a lifecycle activity rather than a single protocol, study, or…
1. Purpose Lifecycle integration and knowledge management in process validation define how data and experience generated across all stages are connected, evaluated, and used to maintain and improve process performance. The objective is to ensure that process validation remains dynamic,…
1. Purpose Regulatory expectations for process validation define what inspectors expect to see to conclude that a manufacturing process is controlled, scientifically justified, and capable of consistently producing quality product. This article reflects inspection perspective and aligns with the U.S….