GMP是国际上对《药品生产质量管理规范》的通称。1999年6月18日，国家食品药品监督管理局发布《药品生产质量管理规范》，并从1999年8月1日起开始正式实施。
GMP is the general name of "Standards for Quality Management of Pharmaceutical Production" in the world. On June 18, 1999, the State Food and Drug Administration promulgated the "Standards for the Quality Control of Drug Production" and formally implemented it from August 1, 1999.
这个规范是药品生产和质量管理的基本准则，适用于药品制剂生产的全过程和原料生产中影响成品质量的关键工序，国家食品药品监督管理局负责认证和发布。
This standard is the basic criterion for drug production and quality management. It is applicable to the whole process of drug preparation production and the key processes affecting the quality of finished products in raw material production. The State Food and Drug Administration is responsible for certification and issuance.