USFDA GMP Regulations

The United States Food and Drug Administration (FDA) protects the nation's health by regulating food, drugs and cosmetics. In 1969, the FDA introduced regulations that require high standards of sanitation and safety for processing, storing and distributing certain products, according to Professor Kevin Keener of Purdue University, These standards, called GMP, or good manufacturing practice, apply to food, drugs and biological products such as blood.

Food

• GMP requires sanitary conditions in the preparation, packing and storing of food. For example, personnel must remove jewelry and wear clothing such as a hairnet and gloves to prevent food contamination. Personnel cannot eat, chew gum, drink or use tobacco in areas reserved for food processing, storage or handling. Anyone having an infectious disease, open sore or infected wound cannot work with food under good manufacture practice regulations. Buildings must have adequate sewage disposal systems, toilet facilities and hand-washing stations. Equipment must be in good working order. Utensils and surfaces that come into contact with food must be cleaned with approved sanitizing products. GMP requires inspection of raw materials used in food preparation and cleanliness of water that washes food. In addition, GMP regulates the effectiveness of containers to prevent deterioration during storage and proper temperature of refrigerated and frozen ingredients.

Drugs

• The FDA requires GMP in all stages of manufacturing, packaging, storing and disposing of drugs including: prescription drugs, over-the-counter drugs and drugs administered to animals. For example, only trained personnel authorized by supervisors can enter a manufacturing area. The walls, floor and ceiling of a building in which drugs are manufactured must be constructed of easy-to-clean, nonporous materials. GMP requires clearly marked, tamper-proof packaging of over-the-counter drugs sold to the general public and identification by batch of prescription drugs. Storage of drugs under conditions required by GMP assures their strength and quality. These conditions include approved temperature, humidity and light. When a manufacturer receives drugs returned for mislabeling, date expiration or other reasons, the manufacturer must destroy the drugs as required by GMP.

Blood Products

• The FDA requires good manufacturing practice of personnel and facilities that collect, process, test, store or distribute blood. Personnel must receive adequate training in GMP to assure the purity of blood collected from donors and supplied to recipients, laboratories, health care facilities and hospitals. GMP requires performance checks of equipment such as thermometers, scales and blood-typing machinery. Facilities that collect, process and distribute blood must prepare written reports and maintain these records for up to 10 years, according to GMP.