What is GMP?
Good Manufacturing Practice or GMP is a set of quality assurance practices promoted by regulatory authorities (including the WHO and US FDA) to ensure manufacturing processes are rigorously set and monitored. GMP guidelines help ensure that manufactured
products like food, cosmetics, and pharmaceutical goods are guaranteed to be safe and of good quality. In addition, following GMP prevents risks of misbranding, contamination, or adulteration of manufactured goods.
In 1992, the WHO GMP was published as a guideline for manufacturing biological and pharmaceutical products. GMP is primarily used across 100 countries including Australia, Europe, China, the Philippines and Vietnam. Each country is responsible for the enforcement
of GMP for their region.
In the United States, GMP is enforced by the US FDA through its Current Good Manufacturing Practices provisions (CGMP) and covers a broader range
of industries such as cosmetics, food, medical devices, and prescription drugs. CGMP regulations contain minimum requirements for methods, facilities
and controls used in manufacturing, processing, testing, and packaging of products. The FDA conducts facility inspections in the US to ensure compliance with CGMP. Serious violations can often lead to product recalls at the FDA’s request.