In order to ensure the quality of drugs, the provisions on various inspection items, indicators, limits and scope are called drug quality standards. The quality standard of drugs is the comprehensive expression of purity, component content, composition, bioavailability, curative effect, toxic and side effects, pyrogen, sterility, physical and chemical properties and impurities of drugs.
Drug quality standards are divided into statutory standards and enterprise standards. Legal standards are divided into national pharmacopoeia, industry standards and local standards. Drug production shall be subject to Pharmacopoeia, drugs not included in Pharmacopoeia shall be subject to industry standards, and drugs not included in industry standards shall be subject to local standards. Drugs that have not set standards and do not meet the statutory standards shall not be produced, sold or used.