Jan 21, 2025 · Regulations help to ensure quality drug products. FDA monitors drug manufacturers' compliance with Current Good Manufacturing Practice (CGMP) regulations. …

Jan 21, 2025 · What are Quality Metrics? For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle.

The goal of manufacturing process development for the drug substance is to establish a commercial manufacturing process capable of consistently producing drug substance of the …

It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities.

Nov 21, 2025 · It’s a fact! Current Good Manufacturing Practices (CGMP) help to establish the foundation for quality pharmaceuticals through regulatory standards.

To bolster pharmaceutical supply chain resiliency in the U.S., FDA has developed a proposal to accelerate the establishment of high priority new pharmaceutical and biological product …

Jul 29, 2025 · FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments.

The U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability …

ICH Q7 provides guidance regarding good manufacturing practices for the drug substance, but does not provide specific guidance on the selection and justification of starting materials.

Oct 11, 2023 · Re-shore drug manufacturing facilities. Helps domestic drug manufacturers compete in a global market. Develop drugs rapidly. Speeds the development of novel or …