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“Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (cGMPs) regulation for human pharmaceuticals.

While drugs represent only one third of the Food, Drug and Cosmetic Act, drugs are impacted by some of the most stringent FDA requirements known collectively as GMPs. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.

This 90-minute accredited training session discusses some facts that may be helpful in understanding how cGMPs per 21 CFR Part 210 and 211 establish the foundation for drug product quality and how it provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.”