Medical network - on April 13, 11, ganzhou city of jiangxi province food and drug administration issued by the ganzhou city drug production supervision priorities for 2017, among them, the qingfeng-xiangguang fracture in jiangxi pharmaceutical co., LTD., jiangxi and pharmaceutical co., LTD., etc. 20 species is listed as key regulatory varieties of drug companies. 

 

 

 

The attached: 

 

Ganzhou city drug production supervision priorities for 2017 

 

In 2017, the city's drug production supervision must be in strict accordance with the provincial work points, combined with the city regulatory practice, adhere to the problem oriented, around "to ensure drug quality and safety and guard against systemic risk" center, down on outstanding issues in the field of pharmaceutical production, to crack down on all kinds of violation behavior in the field of pharmaceutical production, to ensure the quality of pharmaceutical production safety. 

 

One, carry out rectification, eliminate drug production quality and safety hidden trouble 

 

(a) to carry out the rectification of Chinese medicine yinpian production. City bureau will organize inspection, testing and related counties (city, area) bureau of personnel, in accordance with the implementation of Chinese medicine yinpian production enterprise special inspection of the emergency notification "(jiangxi food drug safety drug production [2017] no. 8), concentrating on Chinese medicine yinpian production rectification, falsely making out the bill in accordance with the law, serious processing, dyeing weight, doping ShiJia, outsourcing yinpian branded packaging of lease loan business licenses, illegal production of toxic Chinese medicine yinpian violation behavior, results in newspaper ShengJu before April 5, 2017. 

 

(2) to carry out the rectification of multicomponent biochemical medicine production. Each county (city, area) bureau should organize related to jurisdiction multicomponent biochemical drugs (P - transfer factor, human placenta tissue fluid, etc.) to carry on the special inspection, focusing on multicomponent biochemical drugs raw materials control, crack down on outsourcing others after extraction waste serious violation for production. 

 

(3) to carry out with your fine charge rectification of medicinal materials and rubber products. Key check whether there is your fine herbs (such as bezoar) not feeding or less feeding; Using JiaLie medicinal materials instead of expensive fine medicinal material feeding, etc., such as mules skin, horse skin instead of donkey skin, the use of pig bile, ox-gall instead of snake gall and bear bile feeding, etc. 

 

(4) to carry out the rectification of traditional Chinese medicine extract production. In the area under its jurisdiction to the production and use of traditional Chinese medicine extract enterprise given, carefully accounting the extraction ability and production capacity of enterprises, to extend check, extract to crack down on illegal production, purchase and use for illegal and not according to stipulations for the record extract, etc. The non-legal-person or common extraction workshop, use case, such as extracts from the record of must extend full cover to carry out the inspection. 

 

(5) to carry out the rectification of pharmaceutical production by entrustment. To entrust or illegally accept key check whether there are illegal behavior in the production of drugs, entrust whether both sides to implement their obligations, the production of the product quality is stable. 

 

(6) to carry out the rectification of injection such as high-risk products. Key check enterprise of pyrogen, the control of bacterial endotoxin, asepsis check is in accordance with the requirements, whether strictly complied with the requirements of product stability test. 

 

(7) to conduct special inspection of drug packaging materials production. Key check whether high-risk drug packaging materials production enterprises strictly according to the requirements of production materials, whether in accordance with the approved production formula, process, specification, production records are complete, workshop purification conditions whether meet the requirements; Whether has the registration certificate issued by the state food and drug administration of the drug packaging material, purchase channels is legal, qualification certification is complete. 

 

(8) to carry out special inspection of drug standards implementation. Key check whether enterprise pharmaceutical production and inspection in strict accordance with the statutory standards implementation; Product inspection is carried out in accordance with the standards for all items. 

 

The above eight kinds of questions, each related county (city, area) bureau attaches great importance to, combined with the practice, combing involved in product list, find the root cause, outstanding management focus, focus on action, the key is investigated and the fight against unauthorised changes during the process of production process, illegally added, data fraud and other illegal activities. Each related county (city, area) bureau will be on October 25, 2017 special inspection report the city bureau of medicine production supervision department. 

 

Second, strengthen the key enterprises, key varieties and key links of supervision 

 

(a) each county (city, area) bureau to carry out related to obtaining the pharmaceutical production license of pharmaceutical production enterprise, has the record of extract production enterprises, complete coverage of pharmaceutical preparation of medical institutions supervision and inspection, leaving no regulatory blind spot and blind Angle. 

 

(2) strengthen the regulation key enterprises. Focus on strengthening the production of injection, biochemical drugs, accept foreign export processing or substandard drug, adverse reactions, sampling of the enterprise, such as released alert pharmaceutical enterprises, the new pharmaceutical production enterprise, nearly three years in production for a long time or BanTingChan business, was nearly three years to recover drugs GMP certificate of enterprise's regulation. Each related county (city, area) bureau of supervision enterprises to supervise and inspect the frequency shall not be less than once every six months, the city bureau will spot check of key enterprises. 

 

(3) strengthen the regulation on varieties. Focus on basic drug varieties, shortage of varieties of dosage, selling price varieties, special drugs (including special drug combination), in recent years the unqualified batch more varieties, adverse drug reactions more varieties, new varieties, nearly three years to use fresh bamboo as raw material to the varieties of regulation (see chart). 

 

(4) strengthen the key links of supervision. Focus on strengthening the material supplier audit, all raw materials and finished goods inspection, material balance, disposal of non-conforming product, commissioned the production, cleaning validation, etc. (see chart). 

 

(5) strengthen the supervision of drug production safety. Supervision of dangerous chemicals and the special drug use safety inspection facilities, equipment, safety accessories, strengthen the producing dust, high temperature and high pressure, inflammable, explosive and other key workshop, the key parts of the security monitoring, and leak detection alarm, ventilation, facilities maintenance and operation of inspection for fire and explosion prevention, strengthen the narcotic drugs, psychotropic drugs, toxic medicines (drugs), the precursor chemicals, junduqing and the management of dangerous chemicals. Each related county (city, area) bureau in daily supervision and inspection to strengthen the safety in production supervision, to perform "a pair of responsibilities", ensure safety in production accident of the enterprise. 

 

(6) strengthen the data reliability tests. Check the data reliability as a key content of the whole process of enterprise production, inspection data cannot be traced, not be real situation is serious. 

 

(7) to assist ShengJu urge and guide enterprises to carry out the generic quality of related products and curative effect evaluation of consistency. 

 

Third, establish and perfect drug production supervision mechanism 

 

(a) and to establish drug safety risk analysis system. Each related county (city, area) bureau of drug safety risk analysis to system should be established and according to the characteristics of the regional industry and problems clues, active screening questions, eliminate hidden dangers. Strengthen information exchange and sharing, discovery, risk assessment, risk, risk management and risk communication mechanism. For possible systemic risk to report to the superior departments, so as to take unified action to eliminate risk, adherence to drug safety's bottom line. 

 

(2) to establish a system of joint inspection. City bureau will establish drug production supervision, drug inspection, drug inspection system of joint inspection, unified deployment of the jurisdiction drug production supervision, drug inspection, the inspection personnel, composed of joint inspection teams to carry out supervision and inspection to the pharmaceutical production enterprise each related county (city, area) bureau should actively cooperate with, and combining with the actual, set up a corresponding system of examination. 

 

(3) establish a strict responsibility implementation mechanism. Each related county (city, area) bureau of work to a strict discipline, clear responsibilities, ensure the order, no discounts. City bureau to carry out evaluation appraisal work, strictly implement the pharmaceutical supervisory and administrative accountability and responsibility person. 

 

Fourth, strengthen the unqualified products, varieties of risk warning disposal and hidden perils 

 

(a) seriously deal with unqualified products production enterprise in accordance with the law. For each batch unqualified product will be traced back to check on the source, the terminal to seriously deal with unqualified products in accordance with the relevant enterprises, and public processing results. The supervision enterprise temporary control, product recall and destruction of problem. 

 

(2) through the drug inspection prompt information discovery drug safety hidden trouble. Each related county (city, area) bureau should supervise and urge enterprises to unqualified products and varieties of risk warning in-depth analysis, the reasons of the screen, and extrapolate, find enterprises in the quality guarantee system, raw materials, prescription, production process, packaging, storage and transportation, etc, there may be a problem, and supervise the enterprise earnestly rectification, urge enterprises to improve and improve the quality of raw materials and finished products internal control standards, eliminate the safety hidden trouble. 

 

Fifth, strengthen special drug supervision work 

 

(a) to establish and improve the special drug regulatory mechanism. Conducted on drug precursor chemicals and their preparations, narcotic drugs and wholesale enterprise special inspection of psychotropic drugs of category I, improve the system of special drug regulatory inspections. Actively cooperate with the city's anti-drug work deployment, ensure no special drug abuses occur. 

 

(2) to carry out the apt daily regulatory responsibilities. Each related county (city, area) bureau of production preparation for special drugs and narcotics, regional wholesales enterprises psychotropic drugs of category I and drug precursor chemicals fixed-point wholesale enterprise supervision and inspection, each quarter of not less than 1 times; For other special pharmaceutical trading enterprises and the use of special drugs as a raw material production enterprises, the use of radioactive drugs supervision and examination of the medical institutions, not less than 1 times every six months. 

 

(3) special earnest organization to carry out the second category of psychotropic drugs. Of psychotropic drugs of category ii, especially including codeine compound oral liquid preparation of business enterprise and its related species of special inspection, check the coverage rate was 100%, and the key to verify operating a variety of sales flow, to flow to the downstream units (enterprises) spot check by more than 20% (not less than 5 units). Once found the problem, immediately dealt with according to law, report step by step, and notify the public security organ. 

 

Six, cooperate to do a good job of drug GMP certification 

 

Each related county (city, area) bureau will cooperate with our work for the provincial drug certification center, take an active part in the province's certification on-site inspection, and in strict accordance with the newly revised drug GMP standards. At the same time, strengthen drug GMP inspector team construction, and actively participate in provincial drug certification center organizes all kinds of training, constantly improve the level of regulation in the study. 

 

Seven, strengthen the adverse drug reaction monitoring work 

 

(a) to strengthen the construction of system of adverse drug reactions. Adverse drug reaction monitoring center should be in strict accordance with the formulated ShengJu management way of the adverse drug reaction site disposal site disposal principle and disposal procedures, such as drug sampling on-site disposal, further standardize the adverse drug reaction site disposal procedures. 

 

(2) strengthen the adverse drug reaction monitoring work in data analysis. Adverse drug reaction monitoring center for clustering adverse drug signal behind the implicit information may be associated with drug quality is analyzed, and timely report the relevant drug regulatory department, the information for quick disposal time and win the initiative in a timely manner. 

 

(3) strengthen the pharmaceutical production enterprise adverse reactions to share data verification and analysis of the evaluation work. Each county (city, area) bureau and related adverse drug reaction monitoring center to urge pharmaceutical producing enterprises finish monthly download, check, analysis and evaluation of data, every six months to submit adverse reaction data analysis report, signal extraction risk, basis risk signal risk management measures in a timely manner. 

 

Eight, strengthen the supervision of drug production information submitted to the work 

 

Each county (city, area) bureau according to related ShengJu formulated by the pharmaceutical production and key points of supervision, combining the reality of the jurisdiction supervision, in accordance with the drug production supervision key points in the city to carry out pharmaceutical production quality and safety supervision, and according to the requirements of the report to the information in time.