
Wed, 03/12/2025 - 12:02
Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21…
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…