Mon, 09/23/2024 - 12:03
Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach. Various stakeholders, including the industry,…Thu, 04/11/2024 - 12:02
Risk assessment and continual process verification (CPV) are fundamental regulatory requirements for pharmaceutical companies to ensure drug safety, efficacy, and quality. While risk assessment involves analyzing, mitigating, communicating, and…