ICH Q8 (Pharmaceutical Development)

ICH Q8 (Pharmaceutical Development) is a guideline that provides principles for designing and developing quality medicines. It emphasizes a systematic approach to understanding the manufacturing process and product characteristics to ensure safety, efficacy, and consistency. This involves identifying critical steps and materials, using scientific principles to optimize formulation and manufacturing, and applying risk management. The goal is to develop robust processes that produce high-quality medicines reliably, reducing variability and ensuring patient safety. Overall, ICH Q8 supports innovative and scientifically sound approaches to pharmaceutical development, fostering confidence in the final product.