GMP certification required information: 1. Drug GMP certification application (four copies); 2. "Drug Manufacturing Enterprise License" and "Business License" copy; 3. Pharmaceutical production management and quality management self-examination (including corporate profile and history, production and quality management, the correction of defective items in the previous certification); 4. Drug production enterprise organization chart (indicating the name of each department, interrelationships, department heads); 5. Resume of the person in charge of the pharmaceutical production enterprise and department heads; registration form of pharmacy and related professional and technical personnel, engineers and technicians, skilled workers who have been accredited in accordance with the law, and indicate the department and position; the proportion of senior, middle and junior technical personnel to all employees; 6. Pharmaceutical production enterprises production range of all dosage forms and varieties table; apply for certification range of dosage forms and varieties table (indicating perennial production varieties), including based on the standard, drug approval number; new drug certificates and production approvals, and other copies of relevant documents and information; 7. Pharmaceutical production enterprises around the environment map, general layout, storage layout, quality inspection site layout; 8. Overview of the pharmaceutical production workshop 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, air return, exhaust air 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, major equipment, water systems and air purification system verification; inspection instruments, meters, scales calibration; 11. Pharmaceutical production enterprises (workshop) production management, quality management document catalog.
Edit this section of the drug GMP certification process
1, the reporting enterprise to the provincial bureau of the acceptance of the hall to submit the application for certification and the declaration materials 2, the provincial bureau of drug safety supervision on the form of review of the declaration materials (5 working days) 3, the certification center on the technical review of the declaration materials (10 working days) 4, the certification center to develop an on-site inspection program (10 working days) 5, the provincial bureau of the Approval of the program (10 working days) 6, the certification center to organize the implementation of certification on-site inspection (10 working days) 7, the certification center of the on-site inspection report for the first review (10 working days) 8, the provincial bureau of the certification of the first review of the approval of the views (10 working days) 9, reported to the National Bureau of the review announcement (10 working days)
Edit this section of the drug GMP certification standards
GMP standard (Good Manufacturing Practice) is a system designed to ensure the continuous production of medicines at a specified quality. It is established to minimize the risk of non-conformity in the production of pharmaceutical products.GMP contains requirements for every aspect, from plant to floor, equipment, personnel and training, hygiene, air and water purification, production and documentation. GMP" is an acronym for Good Manufacturing Practice, which means "Good Manufacturing Practice" or "Good Manufacturing Standard" in Chinese. GMP" is an autonomous management system that pays special attention to the implementation of product quality and health and safety in the production process. It is a set of mandatory standards applicable to the pharmaceutical, food and other industries, requiring enterprises from raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control and other aspects of the relevant national regulations to meet the health and quality requirements, the formation of a set of operational practices to help enterprises improve the corporate health environment, and timely detection of problems in the production process, and to improve. Briefly, GMP requires that manufacturers should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the quality of the final product (including food safety and hygiene) in line with regulatory requirements. What is stipulated in GMP is the most basic condition that food processing enterprises must fulfill. Good Manufacture Practice (GMP) is the regulation that guides the production and quality management of pharmaceutical products. The World Health Organization in November 1975 officially announced the GMP standard. The international concept of pharmaceuticals includes veterinary drugs, and only a few countries, such as China and Australia, separate GMP for human drugs from GMP for veterinary drugs.