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. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. What is CGMP?ĬGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. ![]() This paper discusses some facts that may be helpful in understanding how CGMP establishes the foundation for drug product quality. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMP. Most people, however, are not aware of CGMP, or how FDA assures that drug manufacturing processes meet these basic objectives. ![]() ![]() Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Pharmaceutical Quality affects every American. The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals.
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