In 1961, thalidomide caused severe birth defects in thousands of babies. The drug had been sold without adequate testing for safety in pregnancy. The disaster led to stricter drug regulation, including the requirement that manufacturers follow good manufacturing practice. GMP is a system of regulations that ensures pharmaceutical products are consistently produced and controlled according to quality standards.

GMP covers every aspect of production. Facilities must be clean, controlled, and validated. Equipment must be calibrated and maintained. Materials must be tested and traced. Processes must be documented. Personnel must be trained. Every batch must be tested for identity, purity, potency, and safety. Deviations must be investigated. Records must be kept.

The rules vary by country but follow international harmonization efforts. The FDA enforces GMP in the United States. The European Medicines Agency enforces it in Europe. The World Health Organization publishes GMP guidelines for global use. Inspectors conduct audits, and failures can result in warning letters, fines, or bans on selling products.

GMP is expensive. It requires dedicated facilities, trained staff, and extensive documentation. But it is not optional. Without it, drugs cannot be approved or sold. The cost of compliance is the price of trust.