Which act is known for the establishment of Good Manufacturing Practices (GMP)?

The act known for the establishment of Good Manufacturing Practices (GMP) is the Kefauver-Harris Amendment of 1962. This amendment was pivotal in the regulation of pharmaceutical manufacturing and required that manufacturers adhere to strict standards of quality, thereby ensuring that drugs are produced in a consistent manner that meets specific safety and efficacy requirements.

The Kefauver-Harris Amendment emerged in response to public concerns over drug safety and efficacy, particularly following incidents such as the thalidomide tragedy. By mandating GMP, the amendment sought to enhance the safety and quality of drugs available to the public, establishing guidelines that manufacturers must follow throughout the production process.

Other acts, such as the FDA Modernization Act and the Food, Drug, and Cosmetic Act, contribute to the framework of drug regulation but do not specifically originate the GMP concept. The Controlled Substances Act focuses mainly on the regulation of controlled substances and does not pertain directly to GMP standards. Thus, the Kefauver-Harris Amendment is recognized for its direct impact on the establishment of Good Manufacturing Practices in the pharmaceutical industry.