What is GMP?

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Good Manufacturing Practice

Good Manufacturing Practice (GMP) is a system created by law to ensure that products are safe for human consumption. Under this mechanism, manufacturers, processors, and packagers are required to conform to the guidelines and quality standards of the Food and Drug Administration. It is a qualitative approach in ensuring that products are free from contamination and errors. If a company fails to comply with the GMP regulations, it may be subject to certain penalties like closure, recall, or seizure.

Each country has their own legislations implementing GMP standards for manufacturing, testing, and quality assurance. It applies to food, pharmaceutical products, and drugs. GMP generally follows basic principles of food safety and security such as hygiene, contamination control, food evaluation, and ensured distribution. Before products are released from factories, they undergo strict examination to ascertain their quality. If authorities find out that the products are mixed-up or defective, they may order recall or seizure. A sale or supply of defective products may be also subject to confiscation upon the complaint of customers. However, the complaints are also carefully investigated to ascertain their factual bases and truthfulness.

In the United States of America, the mandate of GMP is embodied under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act. It vests power to the court to declare a product as adulterated if it does not pass the required industry standard for manufacturing and processing. The version of GMP in the World Health Organization (WHO) is mainly used as guidelines for pharmaceutical production in almost all countries across the globe. In United Kingdom, the GMP is materialized under the Medicine Act of 1968. Also known as “The Orange Guide,” it sets out the rules and guidelines of how pharmaceutical products are manufactured and distributed. Other countries that have enforced GMP standards are Canada, Japan, Australia, Vietnam, Singapore, and Philippines.