Understanding the Interface Between GMP and Regulatory Affairs in Pharma The Critical Interplay of GMP and Regulatory Affairs in Pharma Compliance Introduction: Why GMP and Regulatory Affairs Must Work in Sync The integration between Good Manufacturing Practice (GMP) and Regulatory Affairs is fundamental to pharmaceutical product lifecycle management. While GMP ensures that drugs are consistently produced and controlled according to quality standards, Regulatory Affairs ensures these processes are aligned with legal frameworks and dossier requirements. The two disciplines intersect across CMC documentation, inspection readiness, post-approval changes, and risk management. A disconnect between these functions can result in regulatory delays, product…