1. Drug GMP certification application (four copies);
2. A copy of "Drug Manufacturing Enterprise License" and "Business License";
3. Self-examination of drug production management and quality management (including enterprise profile and history, production and quality management, correction of defective items in previous certification);
4. Pharmaceutical manufacturing enterprise organization chart (indicating the name of each department, interrelationships, department heads);
5. Resume of the person in charge of the pharmaceutical production enterprise, department heads; according to the law through the qualification of pharmacy and related professional and technical personnel, engineers and technicians, skilled workers registration form, and indicate the department and position; senior, middle and junior technical personnel accounted for the proportion of all employees information table;
6. Pharmaceutical production enterprises production range of all dosage forms and varieties of table; apply for certification range of agents and varieties of table (indicating the year-round production varieties), including based on the standard, the drug approval number; new drug certificates and production approvals, and other relevant documents and information copies;
7. Pharmaceutical production enterprises around the environment map, general layout, storage layout, quality inspection site layout;
8. Overview of the pharmaceutical production plant and process layout plan (including changing rooms, washrooms, human and logistics channels, air locks, etc., and indicate the direction of people, flow and air cleanliness level); air purification system of air supply, return, exhaust layout plan; process equipment layout plan;
9. Application for certification type or variety of process flow diagram, and indicate the main process control points and control items;
10. Pharmaceutical production enterprises (workshop) key processes, the main equipment, water system and air purification system verification; inspection instruments, meters, scales calibration;
11. Pharmaceutical production enterprises (workshop) production management, quality management document catalog.