GMP is a set of mandatory standards applicable to pharmaceutical and food industries, which requires enterprises to meet the hygiene and quality requirements in raw materials, personnel, facilities and equipment, production technology, packaging and transportation, and quality control. , and form a set of operating norms to help enterprises improve the sanitary environment, timely find the problems existing in the production process and improve them.

GMP certification materials:

1, drug GMP certification application (in quadruplicate);

2. Copies of the License for Pharmaceutical Manufacturing Enterprises and the Business License;

3, drug production management and quality management self-examination (including enterprise profile and historical evolution, production and quality management, the correction of previous certification defects);

4, pharmaceutical production enterprise organization chart (indicate the name of each department, relationship, department head);

5 resumes of the person in charge of the pharmaceutical production enterprise and the person in charge of the department; Registration forms for pharmaceutical and related professional and technical personnel, engineering and technical personnel and skilled workers who have passed the examination according to law, and indicate their subordinate departments and posts; Table of the proportion of senior, middle and junior technicians to all employees;

6. List of all dosage forms and varieties within the production scope of pharmaceutical production enterprises; List of drugs and varieties applying for certification (indicating perennial varieties), including standards and drug approval numbers; Copies of new drug certificates, production approval documents and other relevant documents;

7. The surrounding environment, general layout, storage layout and quality inspection site layout of pharmaceutical production enterprises;

8, pharmaceutical production workshop overview and process layout plan (including dressing room, bathroom, people and logistics channels, airlock room, etc.). , and indicate the flow of people, logistics direction and air cleanliness level); Air supply, return air and exhaust arrangement of air purification system; Layout plan of process equipment;

9, apply for certification type or variety of process flow chart, and indicate the main process control points and control items;

10, verification of key processes, main equipment, water production system and air purification system of pharmaceutical production enterprises (workshops); Check the calibration of instruments, meters and weighing instruments;

1 1, catalogue of production management and quality management documents of pharmaceutical production enterprises (workshops).