Good quality drugs are produced, not tested. In order to ensure the quality of drugs and the safety and effectiveness of human medication, the whole process of drug production must be strictly and effectively controlled. However, the phenomenon of violating the production process regulations in drug production is still relatively common, which should be paid enough attention by the drug regulatory authorities. 1 It is not uncommon to violate the pharmaceutical production process regulations in pharmaceutical production. The contents of pharmaceutical production process regulations include: product name, dosage form, prescription, operation requirements of production process, quality standards and technical parameters of raw materials, intermediate products and finished products and matters needing attention in storage, calculation method of material balance, requirements of finished product containers and packaging materials, etc. Pharmaceutical production process regulations run through the whole process of pharmaceutical production, which must be strictly observed and not changed at will. If it is really necessary to change, the procedures for revision and approval shall be handled according to the procedures at the time of formulation.

Key words: technical regulations of drug production, quality standards of production process, drug standards, technical parameters of the whole process of supervision departments, and information on drug registration and application.