ICH Q7 (Good Manufacturing Practice)

ICH Q7 is a guideline for good manufacturing practices (GMP) specifically for the production of active pharmaceutical ingredients (APIs). It ensures that these crucial substances are produced consistently and controlled to quality standards. The guideline covers various aspects, including quality assurance, environment controls, equipment maintenance, and personnel training. By following ICH Q7, manufacturers help ensure that drugs are safe, effective, and of high quality, ultimately protecting public health and enhancing trust in pharmaceutical products.