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Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards. It is important to note that CGMPs are minimum requirements.

Systems and equipment that may have been 'top-of-the-line' to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards. Accordingly, the 'C' in CGMP stands for 'current,' requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.

Drugs are good nofx wiki tab how to#

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. This assures that drug products meet their quality standards. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. 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. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. What are CGMPs?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 CGMPs establish the foundation for drug product quality. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs. Most people, however, are not aware of CGMPs, 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 (CGMPs) regulation for human pharmaceuticals.