Current Good Manufacturing Practice (cGMP) refers to the regulatory framework established by agencies such as the European Medicines Agency (EMA) and Food and Drug Administration (FDA) that defines the minimum requirements for the design, monitoring, and control of manufacturing processes and facilities to ensure the consistent production of safe, effective, and high-quality pharmaceutical and biopharmaceutical products. Compliance with cGMP is mandatory for all clinical and commercial manufacturing activities conducted by CDMOs and pharmaceutical sponsors.
