Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation.
A government, through the regulatory authority for medicines, which can be constituted as a regulatory agency or a regulatory body for medicines, establishes and maintains the rules, laws, and policies required to ensure that medicines (including pharmaceutical products, vaccines, and other biologicals) are safe and effective, and fulfil the quality specifications offered by the producer.