How to apply for pharmaceutical-grade glycerin production license?

According to the "Pharmaceutical Industry Quality Management Regulations" are as follows: Chapter III of the pharmaceutical production, operation of enterprises and varieties of management of the start-up of Article IX of the new drug production enterprises, by the province, autonomous region, municipality directly under the Central Medical Administration (head office) review agreed to prepare for the construction of the completion of the "Drug Administration Law" of the requirements of the organization of the review and acceptance of those who are qualified to issue the "Certificate of Compliance for Drug Manufacturing Enterprises", the enterprise with the Certificate of Compliance" to the health administrative department to apply for "Drug Manufacturing Enterprise License", to the administrative department for industry and commerce to apply for "business license".　　Article 10 to open a drug business enterprises, must be examined and agreed by the local medical management department before the construction, built in accordance with the "Drug Administration Law" of the relevant requirements for inspection and acceptance, qualified, issued by the "drug business enterprise certificate". Business enterprises with this "Certificate of Compliance" to the health administrative department to apply for "Drug Enterprise License", to the administration for industry and commerce to apply for "business license".　　Article XI of the new production of national standards or provinces, autonomous regions, municipalities directly under the Central Government standards of drugs, in the production must be its location by the provinces, autonomous regions, municipalities directly under the Central Pharmaceutical Administration (head office) to check that meets the requirements and issued the "Drug Production License" before the administrative department for the approval of the number of formalities.　　Article XII of the "Drug Manufacturing Enterprises Certificate of Conformity", "Drug Business Enterprise Certificate of Conformity" and "Drug Manufacturing License" format by the State Administration of Pharmaceutical Affairs unified regulations, issued by the State Administration of Pharmaceutical Affairs or provinces, autonomous regions and municipalities directly under the Central Medical Administration (Head Office). Chapter IV standardization and measurement Article XIII of pharmaceutical production and management enterprises must be strictly in accordance with the statutory standards for the organization of pharmaceutical products, production, testing, acquisition and sales.　　Chinese herbal medicines have been issued by the Ministry of "commodity specification standards for medicinal materials," according to the Ministry of standard inspection and purchase, other varieties, each region should develop local standards, according to the local standard inspection and purchase.　　Article XIV in order to ensure that the quality of drugs in the validity period, responsible for the period in line with legal standards, drug manufacturers are required to develop and implement higher than the legal standard of corporate internal control standards.　　Article XV of pharmaceutical manufacturers must develop raw and auxiliary materials, intermediates, semi-finished products have process water quality standards.　　Business enterprises to establish a regular (quarterly, annual) warehouse inventory system.　　Article XVI of the standardization of medical devices should be in accordance with the "standardization of medical devices implementation measures", and by the State Administration of Medicine unified management. National standards for medical devices and professional standards promulgated by the National Bureau of Standards and the State Administration of Traditional Chinese Medicine respectively.　　Article 17 The State Administration of Traditional Chinese Medicine is responsible for organizing the development of national standards and professional standards for pharmaceuticals, packaging materials for medical devices, pharmaceutical machinery, storage and transportation. National standards and professional standards shall be promulgated and implemented by the State Bureau of Standards and the State Administration of Traditional Chinese Medicine respectively.　　Article 18 Major changes in the production process route of pharmaceuticals shall be identified and approved in accordance with the regulations, and shall be revised or supplemented in accordance with the changes in quality standards or test methods, and the quality of its products shall not be lower than the standard level of the original production process route.　　Article 19 In accordance with the requirements of the "Measurement Law", the pharmaceutical production enterprises must be required to set up measurement management organizations, with full-time measurement of management personnel, the establishment of measurement management system, equipped with the necessary measuring instruments and equipment, and regular calibration and maintenance.　　Article 20 of the pharmaceutical production enterprises in accordance with the "industrial measurement of the work of grading and upgrading methods (for trial implementation)" provisions should be obtained "three-level measurement of the Certificate of Conformity". Won the national product, the State Administration of Pharmaceutical Quality Management Award enterprises, must obtain the "secondary measurement certificate". Chapter V Quality Management System Article 21 of the pharmaceutical production and management enterprises, must develop and strictly implement the quality management system to ensure the quality of pharmaceutical products.　　Article 22 The product quality file system. Pharmaceutical products should be established product quality records. Contents include: the use of raw and auxiliary materials, packaging materials, parts and other quality standards, process technology routes (prescription), quality standards of change, the improvement of testing methods, the completion of the quality indicators, and the gap between domestic and foreign advanced level, the sample observation data, rework returns, major quality accidents and the user to reflect the views and so on.　　Business enterprise commodity quality files include: purchased (transferred) into the commodity quality standards, purchased commodity inspection records, quality changes, quality problems with the handling of commodities, user inquiries and so on.　　Article 23 quality analysis system. Pharmaceutical production enterprises must adhere to the factory level, workshop, group of regular three-level quality analysis meeting system. Respectively by the factory director, workshop director, team leader presided over, analyze the quality of the situation, study the development, improvement and enhancement of quality measures.　　Pharmaceutical business enterprises should establish a regular quality analysis system, chaired by the manager, analyze the quality situation, put forward measures to improve and strengthen quality management.　　Article 24 Sample retention and observation system. Pharmaceutical companies should seriously carry out observation of the sample, a person in charge, regular re-inspection, observation, make a good record, the establishment of the sample file. Observation of product quality stability through sampling to examine.　　Article 25 of the commodity storage and maintenance system. Pharmaceutical companies should be stored in accordance with the specified conditions of commodities, to observe the quality of its changes, make a record. To implement the "first in, first out", "near expiration date first out" provisions. To strictly control the "acceptance of storage, in the storage of maintenance, storage and distribution of inspection".　　Article 26 quality statistics reporting system. Pharmaceutical production enterprises should be in accordance with the provisions of the National Bureau of Statistics formulated statistical reports, regularly to the provinces, autonomous regions, municipalities directly under the Central Government of the professional companies to report, while reporting the local Pharmaceutical Affairs Bureau (head office) and the State Administration of Pharmaceutical Affairs of the relevant professional companies. Provinces, autonomous regions, municipalities directly under the Central Medical Administration (head office) reported to the State Administration of Quality Standards Division. The content should have text description and reason analysis. Each statement to maintain the continuity of the content, the basis of quality statistics should be implemented in accordance with the uniform provisions, shall not be changed arbitrarily.　　Article 27 quality accident reporting system. Pharmaceutical production and management enterprises in the event of quality accidents, should be seriously and quickly dealt with, and promptly reported to the competent authorities at each level. Quality accidents are divided into general accidents and major accidents. The scope of major quality accidents: (1) due to the occurrence of quality problems caused by the whole batch of finished products scrapped; (2) pharmaceutical products in the responsible period or warranty period due to quality problems caused by the whole batch of return; (3) in the library of pharmaceutical products, due to poor storage caused by the whole batch of insects, mold and mildew deterioration, contamination and damage and other can no longer be used for medicinal purposes; (4) product mixing occurs in the medicines, serious mixed or other foreign substances of poor quality, and a serious threat to (5) due to quality problems in each batch (times) caused by the following economic losses (working hours are not counted), chemical drugs and medical equipment manufacturers more than 5,000 yuan (including 5,000 yuan); traditional Chinese medicine manufacturers and pharmaceutical companies more than 3,000 yuan (including 3,000 yuan); (6) export of pharmaceutical products, due to quality problems, returns, claims, or accidents caused by the impact of the worse. (6) Exported pharmaceutical products, due to quality problems returned, claims or accidents caused by the worse impact.　　All of the above are regarded as major quality accidents.　　The occurrence of quality problems caused by personal death or the nature of the bad, bad impact of major quality accidents, the enterprise should be reported within 24 hours to the local pharmaceutical management bureau (head office), the professional company at the same time reported to the State Administration of Pharmaceutical Affairs and the relevant professional companies. The rest of the major quality accidents should also be reported within three days by the enterprise to the Bureau and the professional company to investigate the cause, and then make a written report, generally no more than 15 days. General accidents are reported with the monthly quality report.　　Where major quality accidents do not report, to track down the enterprise quality supervision department and factory director (manager) responsibility. And for concealing quality accidents, depending on the circumstances, to be criticized, informed or disciplinary action.　　Article 28 user access system. Pharmaceutical production and management enterprises should establish "all for the user" the idea of service, do a good job after the sale of technical services, regular user visits to investigate the quality of pharmaceutical products after the factory to reflect the existence of the problem and study the improvement measures, medical equipment to implement the "three packages ". The people's letters reflecting the quality of pharmaceutical products, should be carefully verified and properly dealt with in a timely manner.