18^th European Biosimilars Congress

Pharmaceutical Regulatory Affairs And IPR

Good Manufacturing Practices quality of drugs is essentially the responsibility of manufacturers. GMP Guidelines are means to assure this very quality of drugs. CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. GMP is actually good common sense quality management quality assurance GMP production and quality control.