Certification materials required for the new version of GMP certification
GMP is a set of mandatory standards applicable to the pharmaceutical, food and other industries. It requires enterprises to meet the hygienic quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, and quality control, and form a set of operable The operating specifications help enterprises to improve the sanitary environment of the enterprise, find out the problems existing in the production process in time, and improve them. As a relatively complete management system, the strict implementation of GMP is beneficial to the healthy development of my country's pharmaceutical industry. Implementing GMP and strengthening quality management is the way to survive and develop. The following will introduce the main 11 certification materials of the new version of GMP certification: 1. GMP certification application form (in quadruplicate); 2. Copies of 'Production Enterprise License' and 'Business License'; 3. Production management and quality management Check the situation (including the company profile and historical evolution, production and quality management, and the correction of defects in the previous certification); 4. Organization chart of the production enterprise (indicate the name of each department, mutual relationship, and the person in charge of the department); 5 . Resumes of the person in charge of the production enterprise and the person in charge of the department; the registration form of the pharmacy and related professional and technical personnel, engineering technicians, and technical workers who have been qualified according to law, and indicate the department and position; senior, middle and junior technical personnel account for all employees. Proportion table; 6. List of all dosage forms and varieties in the production range of the production enterprise; list of agents and varieties for the scope of application for certification (specify the annual production varieties), including the basis of standards, approval numbers; copies of new drug certificates and production approval documents and other relevant documents and materials 7. The surrounding environment map of the production enterprise, the general floor plan, the warehouse floor plan, and the floor plan of the quality inspection site; 8. The general situation of the production pharmaceutical cleanroom and the floor plan of the process layout (including changing rooms, toilets, flow of people and logistics channels, air 9. The process flow chart of the type or variety applying for certification, And indicate the main process control points and control items; 10. The verification status of the key process, main equipment, water production system and air purification system of the workshop decoration of the production enterprise (workshop); the verification status of the inspection instruments, meters and weighing instruments; 11. Production enterprise (workshop) production management, quality management file catalog.
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