GMP guidelines ensure the quality, safety, and efficacy of pharmaceutical products by establishing consistent manufacturing standards.
The Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of drugs in the United States.
A CoA provides detailed information on the quality and compliance of a pharmaceutical product batch, ensuring it meets predefined standards.
Pharmacovigilance is the science of detecting, assessing, and preventing adverse effects of pharmaceutical products to ensure patient safety.
An NDA submission includes detailed documentation such as clinical trial data, manufacturing information, and safety studies to seek regulatory approval.
ICH guidelines harmonize technical and scientific standards to ensure consistent quality, safety, and efficacy across different regulatory regions.
