7. Drug standards and regulations

7.1 In the world

To guarantee the potency and purity of active ingredients, as well as the quality of finished products, the manufacture of pharmaceutical products must comply with strict standards. These standards, drawn up after worldwide consultation with several qualified bodies including ISO, USP (United States of Pharmacopeia), ASTM (American Society for Testing and Materials), NIST (National Institute of Standards and Technology), etc., guarantee safe and effective products. WHO defined its own GMPs (Good Manufacturing Practices) in 1967, based on the "Current Good Manufacturing Practices" already in use in the USA since 1963. In this respect, the WHO recommends that regulatory requirements be based on compliance with good practices for controlling the quality, safety and...