Good Manufacturing Practice Regulations

Manufacturing firms have to adopt certain practices to operate efficiently.

The consumer is faced with the task of selecting the right product from a range of products on the market. In making this choice, quality and safety are crucial. Good Manufacturing Practice (GMP) regulations ensure that companies manufacture high-quality products and minimize contamination.

Definition

Good manufacturing practice refers to a quality assurance system that manufacturers use to ensure that their products are of high quality. GMPs guide the production and testing of products. These regulations are legally binding worldwide, but GMP guidelines vary between countries.

Basic Principles

All GMP regulations follow some basic principles, ranging from documentation to complaint handling. One principle requires manufacturers to put into place a system for recalling any lot of drug from trade or supply. Proper documentation of manufacturing processes is also a principle of GMP regulations. This documentation must be written in simple language.

Enforcement

GMP regulations are enforced by regulatory bodies in their respective countries. The Food and Drug Administration (FDA) enforces these regulations in the United States using the phrase "current good manufacturing practices." Regulatory agencies such as the FDA are authorized to make both surprise and scheduled inspections of manufacturing companies.

References

• U.S. Food and Drug Administration: Regulatory information.
• ISPE: What Is GMP?
• U.S. FDA: Facts About Current Good Manufacturing Practices (cGMPs)