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Current Good Manufacturing Practices (cGMP) Basics

Current Good Manufacturing Practices Basics Current Good Manufacturing Practice regulations (cGMPs) are used by pharmaceutical, medical device, and food manufacturers as they produce and test products that people use. In the United States, the FDA has issued these regulations as the minimum requirements. Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing human and veterinary products (21 CFR 210-211), medical devices (21 CFR 820), and processed food (21 CFR 100). cGMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced according to cGMP are safe, properly identified, of the correct strength, pure, and of high quality.

The cGMP basics course will acquaint students with the history and background of the U.S. FDA and its Current Good Manufacturing practices. The five values found in cGMPs (safety, identity, strength, purity and quality) will be examined. Individual and group exercises will provide learners a chance to discover how to perform job functions to assure that cGMP values are maintained.

Prospective or current employees who might benefit from this course include individuals interested in becoming pharmaceutical operators, manufacturing assistants, and quality assurance/control specialists.