It can be summarized as wet end, hardware and software. Wet department refers to personnel, hardware refers to factories, facilities and equipment, and software refers to management regulations such as organization, system, technology, operation, hygiene standards, records and education.

(1) personnel: a certain number of professional and technical personnel are needed, and all staff members need to be trained in professional knowledge and GMP knowledge;

(2) Factory facilities should meet the requirements of GMP cleanliness level, and drugs must be produced in clean areas. The production equipment used should be advanced and applicable, easy to clean, and must not change with drugs (generally made of stainless steel);

(3) Software: perfect technical standards, management standards, working standards and record vouchers should be formulated, including production, technology, quality, equipment, materials, verification, sales, workshop, purification system, administration, health and training.