Evolution of GMP in Pharmaceutical Industry

Drugs are not ordinary consumer products and in most of the instances, consumers are not in a position to make decisions about quality of the drugs, hence the production of medicines, their distribution and dispensing also requires special knowledge and expertise 1. Since our ancestors began trading several years ago, counterfeit and substandard medicines have been a recurring problem, with history punctuated by crises in the supply of anti-microbial, such as fake cinchona bark in the 1600s and fake quinine in the 1800s. [...]foods and cosmetics may be subject to the drug requirements of the law if therapeutic claims are made for them. Good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and colour additives, animal food additives human and animal drugs, medical devices for human use, biological products, and electronics products. The ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide.