GMP Compliance: Understanding FDA Good Manufacturing Practices

Good manufacturing practice (GMP) refers to a quality control system maintained by the U.S. Food and Drug Administration (FDA). Chapters IV and V of the Federal Food, Drug, and Cosmetic Act authorize the FDA to establish and regulate GMP guidelines.

Features

• GMP guidelines apply to manufacturers of food, biologics, drugs and medical devices. These guidelines include regulations for sanitation, cleanliness, record keeping, process validation and personnel qualifications.

Function

• GMP guidelines keep consumers safe by ensuring products are safe and effective. Consumers usually cannot detect unsafe products, since contaminated or unsafe products often look and taste the same as safe products.

Considerations

• GMP guidelines are broad and general, allowing manufacturers flexibility in how they design their quality systems and manufacturing processes.