Medical network - April 1 on March 29, jiangxi food and drug administration issued by the "drug production supervision key points in jiangxi province in 2017", points out that in 2017, the provincial drug production supervision work to insist on the guidance, continue to around in order to "ensure drug quality and safety, prevent systemic risk" as the 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, effectively eliminate the drug safety hidden trouble. 

 

Pharmaceutical field always is the important content of deepening the reform of medical health system, is the medical treatment, health care, medical reform, scientific and technologic is important one annulus. Recently, the national drug regulatory work conference pointed out that in 2016, the relevant departments to initiate an investigation in the field of circulation enterprises 1383, revocation of the pharmaceutical trade license, 40, the cancellation of the pharmaceutical trade license of 207, revocation of drug GSP certificate 172, 47 cases transferred to public security organs. Take medicine GMP certificate of eight production enterprises, 2 cases transferred to public security organs. 

 

Wu zhen, deputy chief of the state food administration of drug safety, said in 2017, in pharmaceutical production link, will continue to do a good job in multicomponent biochemical medicine, Chinese medicine extract, rubber products renovation work, emphasis is investigated and the fight against change process without authorization, illegally added in the process of production, data fraud and other illegal behavior, the data cannot be traced, unreal to serious processing. 

 

According to comb, 39 medicine king "the jiangxi province in 2017 drug production supervision work key point for such outstanding problems as shortage of drugs in the province are of variable quality, variety, from production, circulation, use the whole chain, the whole process eight targeted reform measures are put forward. 

 

A pharmaceutical production, centralized regulation field 

 

In multicomponent rectification of biochemical medicine production. Key inspection enterprise multicomponent biochemical drugs raw materials control, crack down on outsourcing others after extraction waste serious violation for production. 

 

Carry out with your fine charge rectification of medicinal materials and rubber products. Key inspection enterprise whether there is a charge or less expensive fine herbs not feeding, such as bezoar expensive fine herbs not 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. 

 

To carry out the rectification of Chinese medicine yinpian production. Forward according to the state food and drug supervision and administration bureau on further strengthen the regulation of Chinese medicine yinpian production and operation notice (jiangxi food drug safety drug production [2015] no. 40), concentrating on Chinese medicine yinpian production rectification, especially Chinese medicine yinpian dyeing weight, doping ShiJia, outsourcing yinpian branded packaging of lease loan licenses must be processed in accordance with the serious problems, such as, ShengJu to spot check to check condition. 

 

In traditional Chinese medicine extract production rectification. 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 proprietary Chinese medicine home city bureau must extend full cover to carry out the inspection. 

 

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. 

 

Begin the rectification of risky products such as injection. 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. 

 

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

 

Each city bureau to carry out of the province of the pharmaceutical production license pharmaceutical production enterprise, has been put on record of extract production enterprises, traditional Chinese medicine formula particles producing enterprises, pharmaceutical preparation of medical institutions covered by the supervision and inspection, leaving no regulatory blind spot and blind Angle. 

 

Strengthen the regulation key enterprises. Focus on strengthening the production of injection, blood products, accept overseas processing or export medicines, medicinal hollow capsules of enterprises and convergence adverse reaction occurred, unqualified sampling observation of quality problems, such as enterprise, was published risk warning and drug companies, the new pharmaceutical production enterprise, nearly three years for a long time in the production or BanTingChan business, was nearly three years to recover drugs GMP certificate of enterprise's regulation. The city bureau of supervision enterprises to supervise and inspect the frequency shall not be less than once every six months. 

 

Strengthen the regulation key varieties. Key to strengthen basic drug varieties, shortage of varieties of dosage and varieties of selling price, special drugs (including special drug combination), in recent years, the unqualified batch more varieties, adverse drug reactions more varieties, new varieties, nearly three years, the use of fresh bamboo as raw material variety regulation. 

 

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 production, such as cleaning validation regulation. 

 

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. 

 

Strengthen the data reliability tests. Check the data reliability as a key content of enterprise production, inspection to check the whole process of data, to find data cannot be traced, not the real serious processing. 

 

Third, establish and perfect drug production supervision mechanism 

 

To establish drug safety risk analysis system. ShengJu will establish working group on drug safety risk analysis, risk analysis to meeting regularly, collecting all kinds of risk information, carry out comprehensive analysis, the analysis judgment risk factors, determine the risk level and research to develop targeted prevention and control measures. Each city bureau also want to establish drug safety risk analysis system, in view of the region industry characteristic and problem of 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. 

 

Set up joint examination and joint working system. Around to establish drug production supervision, drug inspection, the drug inspection joint inspection and joint working system, 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 department personnel respectively from different angles to carry out an overall supervision and inspection on pharmaceutical production enterprise. 

 

Establish a strict responsibility implementation mechanism. Around to have strict work discipline, with the responsibility to carry out the discipline of rigid constraints to the concrete work, ensure the order, no discounts; Regularly to subordinate departments to carry out the 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 

 

In accordance with the serious of dealing with the unqualified products enterprises. To produce unqualified products processing, and processing result in public. For each batch unqualified product will be traced back to check on the source, the terminal, seriously deal with unqualified products in accordance with the relevant enterprises. The supervision enterprise temporary control, product recall and destruction of problem. 

 

Through drug inspection prompt information discovery and drug safety hidden trouble. To unqualified products and risk warning products, the reasons of the in-depth analysis and screening, 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 

 

Will be apt to special inspection combined with perfect mechanism. To carry out the drug precursor chemicals and their preparations, narcotic drugs and wholesale enterprise special inspection, psychotropic drugs of category I and take this opportunity to strengthen the summary refining, improve the system of special drug regulatory inspections. 

 

To carry out the apt daily regulatory responsibilities. For special drug manufacturing enterprises and narcotic drugs, regional wholesales enterprises and drugs psychotropic drugs of category I kind of 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. 

 

Carry out special campaigns against the problem. To carry out the psychotropic drugs of category ii especially containing codeine compound management special inspection of the oral liquid preparations, do check the coverage of 100%, the key to verify its 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, and notify the public security organs, the reported ShengJu. 

 

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

 

Serious drug GMP certification inspection on the spot. Provincial drug certification center to continue to do a good job of newly revised drug GMP certification, especially the national administration of devolution of aseptic drug certification, should organize the most powerful force to field inspection by the certification, to ensure that aseptic drug certification on-site inspection will be implemented strictly according to the new drug GMP standard. 

 

To strengthen the construction of pharmaceutical GMP inspector team. To create conditions for the construction of our province professional drug inspector team, provincial drug certification center to strengthen the training and examination of the inspector, the deployment of disobedience, not to participate in training, failed in the exam, or check the work, there are serious errors cancel inspector qualification. 

 

Seven, strengthen the adverse drug reaction monitoring work 

 

To strengthen the construction of system of adverse drug reactions. Province adverse drug reaction monitoring center to develop the adverse drug reactions the site disposal measures for the administration of the drug adverse reactions to the scene disposal principle and disposal procedures, such as drug sampling make specific provisions, further standardize the adverse drug reaction site disposal procedures. 

 

Strengthen the adverse drug reaction monitoring data analysis. Province 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. 

 

Strengthen the pharmaceutical production enterprise adverse reactions to share data verification and analysis of the evaluation work. Around a month to supervise the pharmaceutical production enterprise finish 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 

 

To develop and submit the drug production supervision points (plan). Formulated according to the city bureau ShengJu drug production supervision point, combining the reality of the jurisdiction supervision, making the city's drug production supervision points (plan), clear the enterprise supervision key varieties and key link. The metro will set in April 2017, 15 (plan) to the points of supervision ShengJu. 

 

To develop and submit the drug production supervision system. The city bureau should attach great importance to drug production supervision system construction, on November 30 2017 will submit ShengJu this notification requirement of working system.