Materials required for GMP certification: 1. Application for GMP certification of drugs (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, correction of previous certification defects); Organization chart of the pharmaceutical production enterprise (indicating the name, relationship and 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 environmental map, general plan, storage plan and quality inspection site plan of the pharmaceutical production enterprise; 8. General situation and process layout of pharmaceutical production workshop (including dressing room, bathroom, pedestrian and logistics passage, air lock, 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. The process flow chart of the type or variety to be certified, and indicate the main process control points and control items; 10. Verification of key working procedures, 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).

Edit this GMP certification process.

1. The reporting enterprise submits the certification application and application materials to the acceptance hall of the provincial bureau. 2 provincial drug safety supervision department to review the application materials (5 working days). 3. The Certification Center shall conduct technical review of the application materials (10 working days). 4. The certification center shall make an on-site inspection plan (10 working days). 5. The provincial bureau approved the scheme (65438+) and the certification center organized and implemented the on-site inspection of certification (10 working days). 7. The certification center conducts a preliminary examination of the on-site inspection report (10 working days). 8. Preliminary examination opinions of the provincial bureau for approval and certification (10 working days). 9. Report to the National Bureau for review announcement (10 working days).

Edit this drug GMP certification standard.

GMP standard (Good Manufacturing Practice) is a system to ensure the continuous production of drugs under specified quality. It is to minimize the risk of unqualified drugs in the production process. GMP covers all aspects of requirements, from workshop to ground, equipment, personnel and training, hygiene, air and water purification, production and documentation. "GMP" is the English abbreviation of Good Manufacturing Practice, which means "good working standard" or "good manufacturing standard" in Chinese. It is an independent management system, paying special attention to product quality and health and safety in the production process. It is a set of mandatory standards applicable to medicine, food and other industries, and requires enterprises to meet the hygiene and quality requirements in raw materials, personnel, facilities and equipment, production technology, packaging and transportation, quality control and so on. , form a set of operating norms to help enterprises improve the sanitary environment, and find out the problems existing in the production process in time and improve them. In a word, GMP requires production enterprises to have good production equipment, reasonable production technology, perfect quality management and strict testing system to ensure that the quality of final products (including food safety and hygiene) meets the requirements of laws and regulations. The content specified by GMP is the most basic condition that food processing enterprises must meet. GMP) is a regulation that guides drug production and quality management. The World Health Organization officially announced the GMP standard 1975 1 1 in June. The international concept of drugs includes veterinary drugs. Only a few countries, such as China and Australia, separate GMP of drugs for human use from GMP of veterinary drugs.