Pharmaceuticals and the CGMP

CGMP stands for Consolidated Gauge Marketing Plan. These are guidelines governed by the Food and Drug Administration’s National Marketing Service. Good manufacturing practices are the processes required to comply with the standards recommended by regulatory agencies who regulate the production and distribution of foods, cosmetics, pharmaceuticals, dietary supplements, and other health products. In the United States, the FDA is responsible for regulating cosmetics, dietary supplements, medical devices, food, drugs, biologics, veterinary products, personal care products, nursery crops, animal biotechnology, and tobacco. The Agency manages and implements quality standards throughout the manufacture and distribution of these products.

 

All companies manufacturing or distributing a wide range of products are expected to have policies in place that comply with the standards and guidelines set forth in the CGMP. Every company should develop a plan for quality management and ensure that they maintain the policies in place. If a company observes bad manufacturing practices, they can be held accountable through the actions of their management, product recalls, warnings, and fines. It is the responsibility of regulatory agencies to determine whether or not a company is in violation of their standards and keep tabs on them through the corrective and preventive measures set forth in the CGMP. A company with good manufacturing practices will be encouraged to continue to improve their practices and those that are found to be in violation of the guidelines will be required to make necessary changes. Every member of an organization that makes or distributes products to consumers must take a course of action that meets the requirements of the CGMP.

 

Quality management refers to the entire process from conception to bottling, from shipping to final distribution. If a company’s quality metrics program is found to be defective, it can result in product recalls, product liability, and other serious consequences. The failure to adhere to the current good manufacturing practices guidelines can place both the manufacturer and the distributor in violation of their manufacturing policies, which can result in a loss of business. The failure to comply with the Current Good Manufacturing Practices guidelines and the CGCM will have a direct and negative impact on the pharmaceutical industry, negatively impacting the sales of pharmaceutical products and services and ultimately the bottom line of the pharmaceutical firm.