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    Home > Active Ingredient News > Drugs Articles > Promotion of national health food and Drug Administration hiring drug inspectors

    Promotion of national health food and Drug Administration hiring drug inspectors

    • Last Update: 2017-01-06
    • Source: Internet
    • Author: User
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    [industry trends of chinapharma.com] on December 29, the State Food and Drug Administration held a ceremony in Beijing to issue certificates and swear oath for newly appointed drug inspectors Bi Jingquan, director of the State Food and drug administration, said he had raised expectations for drug inspectors and put forward his own views on how to be a qualified inspector The following is the original speech (picture source: Baidu picture) comrades: near the end of the year, we specially issue the inspector certificate for the newly appointed drug inspector and hold the oath ceremony for the inspector First of all, congratulations Let me make three comments I from 2015, we started to prepare for the appointment and renewal of inspectors We have held four training courses on the appointment of national GMP inspectors and one training course on the inspection of blood products inspectors, and passed the on-site inspection and assessment This year, we have announced to the public in two batches, employing 649 drug inspectors Drug inspection is very important and it's glorious to be an inspector In particular, you can pass the recommendation of the Provincial Bureau, the training and assessment of the General Administration and experience the elimination rate of nearly 50%, which shows that your professional technology is excellent and your business ability is top-notch Inspectors are not only the high honor of inspectors, but also a group with high and strong ability of drug inspection in China Drug inspector is not only an honor, but also a responsibility All of them come from the departments and bureaus of the General Administration, the inspection institutions and inspection institutions of all regions, some from the local review institutions, as well as the adverse reactions monitoring institutions, etc But you have a common identity, which is "drug inspector" When you carry out the inspection task, you represent the image of China food and drug administration, its ability and its level Your responsibility is to ensure the quality of Chinese food and medicine and the health of the people I hope you will keep in mind today's oath, fulfill your duties, fulfill your mission, maintain the image of the inspection team, safeguard the honor of China's food and drug inspection agency, and be loyal guardians of people's health Drug inspectors should dare to adhere to the principle The clinical trials, production process, transportation, storage and sales of drugs are strictly regulated These specifications are our inspection standards The problems found in the inspection must be truthfully recorded, truthfully reflected, scrupulous and selfless We will never let go of any problems that may affect the quality of drugs and the safety and effectiveness of drugs Everyone has an important responsibility in promoting the industry to form an atmosphere of advocating science, respecting science, making medicine with conscience and abiding by laws and disciplines In the inspection of drug registration stage, we should focus on the authenticity, consistency and the feasibility of listing, and strictly control the listing of drugs In the GMP follow-up inspection, it is necessary to ensure the continuous compliance of the production process and the integrity, authenticity and traceability of the data In the inspection of causes, we should dare and be good at exposing "hidden rules" and crack down on illegal behaviors Drug inspectors should be strict with discipline The inspection involves the overall situation of drug supervision The greater the responsibility, the higher and stricter the requirements Inspectors should obey the arrangement, command and command just as soldiers go to the battlefield; they should perform inspection responsibilities in strict accordance with GCP, GMP, GSP and other specifications; they should not release water or be selfish; they should complete the specified inspection workload, learn new knowledge constantly, and always keep sensitivity to inspection work; We must strictly abide by the confidentiality discipline, and shall not divulge the process secrets and business secrets of the enterprise, and shall not divulge the work secrets of inspection Second, how to be a qualified inspector first of all, we should be devoted to our duties Inspectors should be "loyal" First, we should be loyal to the party and the people Inspector is the representative of public interest, the executor of state public power and the watchman of people's health Therefore, we must perform our duties in a spirit of high responsibility for the cause of the party and the people Second, be loyal to the law Laws, regulations, rules and regulations, which are the "rules of heaven" that every drug practitioner must strictly abide by, should be respected by the regulators and the regulated Our inspectors are the maintainers and executors of these "tiantiao" Third, we should be loyal to the cause of food and drug supervision Food and drug supervision is a public service and an important part of the public safety system To ensure the quality and safety of food and drug is the sacred duty of our food and drug regulatory department To fulfill this sacred duty, we need our inspectors to strictly enforce the law online If you choose this career and devote yourself to it, you must be loyal to it and to it Second, we should have five abilities One is the ability to judge right and wrong During inspection, it seems to be easier to judge whether it is illegal or not, but online inspection may be a matter of minutes Every inch of difference is a thousand miles of error We should have the concept of distinguishing right from wrong and the ability to judge right from wrong It needs professional knowledge and courage to judge whether each index is qualified It reflects the ability and quality of inspectors Second, the ability to find problems Food and drug supervision focuses on finding problems and hidden dangers, and whether problems can be found, which is a major test of inspectors' ability Only when problems are found and raised can problems be solved, hidden dangers be eliminated, and the quality and safety of food and drugs be guaranteed Third, the ability to check and handle cases We are required to punish everyone for every illegal case Our current inspection of administrative law enforcement often focuses on the illegal behaviors of enterprises, but the illegal behaviors are committed by specific people In the future, in the inspection and inspection of food and drugs, the direct responsible person and indirect responsible person shall be responsible for any problems found in violation of laws and regulations Only when the punishment for every illegal act is imposed on natural persons can we be deterred by such inspection and punishment This requires our inspectors to learn to collect evidence, and the inspection records made on the spot should have legal effect in the court Fourth, the ability to study inspection methods At present, our food and drug inspection and inspection have stipulated standards and codes of conduct However, some enterprises and individuals, in order to pursue the maximization of interests, try their best to avoid these standards and norms Check according to the existing standards and specifications It may be qualified, but there are also "false negative" To solve these problems, we need to be good at discovering, dare to expose, and study ways to break these "hidden rules" Rectifying Ginkgo biloba preparation is a good case Our inspectors should have the ability to research and develop methods So inspectors should also do scientific research You should have a lot of practical experience and be good at finding clues Fifth, the ability of writing We need a large number of inspectors We hope that the inspectors will not only be able to do their own work, but also be able to communicate, summarize, write articles, compile textbooks and take apprentices To write an article, you should have a clear point of view, a rigorous logic, accurate data and concise language You are the seed When you sow it all over the country, you will bring a large number of qualified inspectors to drive the improvement of the whole food and drug inspection capability Third, we should be familiar with four aspects of knowledge First, be familiar with the professional knowledge of food science and drug science In the inspection of food and medicine, we need to know the relevant professional knowledge, what is its composition, what kind of chemical principle and what kind of production process This is the line of inspectors Food and drug inspection is a professional work, there is a threshold, not everyone can do it Second, be familiar with the basic knowledge of law and law We are performing our official duties and representing the power of public power We need to understand the procedures of the law, how to collect illegal evidence, and make the procedures legal and the evidence effective Especially in checking and handling cases, the prosecution and proof should be legal Third, be familiar with the basic knowledge of computer application Check the R & D, production and operation of the enterprise, require the data to be recorded truthfully and timely, and all data shall be traceable and not be tampered with Now enterprises have realized computerized management Inspectors should be familiar with the basic knowledge of computer application Of course, it is better to understand the professional knowledge of computer, which is also an important test of our inspection ability Fourth, have basic knowledge of financial analysis Any illegal act that has economic interests has profit making motive In last year's ginkgo leaf preparation case, the cost of a plate of 24 ginkgo leaves can't be less than 1.8 yuan, but some enterprises can actually sell it to 1.2 yuan How can we make this medicine without fraud? Some say that the loss of this product depends on the profit of other products, and this reason can't stand Selling medicine at a price lower than the cost will crush legal and legal enterprises This is unfair competition, an economic crime, and it will damage the public interest Now we should pay special attention to the phenomenon of "virtual low" in addition to the virtual high of drug prices If the price is so low and the product is still qualified, this is the risk we should pay attention to in drug inspection and inspection So we should learn the knowledge of economics and the knowledge of enterprise financial accounting Fourth, we should cultivate three styles of work First, a scientific and pragmatic style of work This is the truth Only when we don't cheat can we return to science Inspectors must be scientific and pragmatic, do not abuse or abuse people, and do not condone illegal activities Second, a rigorous and meticulous style of work In the world, we are afraid of being serious The Communists are serious What the inspector does is meticulous work I just saw the display board of your work Some inspectors went to the countryside to check the clinical trial results of vaccines and lit candles to light up the night battle There is also the verification of clinical trials It is not easy to see contradictions and problems in so many clinical trial data In order to find the illegal signs and to explore and restore the illegal facts behind them, we need to be rigorous and meticulous Third, the style of doing things in a vigorous manner An inspector's task is like a soldier's command to take a gun and go to war Inspection is a very important part of the whole food and drug supervision, which is related to the overall situation In particular, some due to inspection may start within a few hours after finding problems, and some cases are transient Therefore, we must obey the dispatching and orders In particular, part-time inspectors usually have their own work, but when there are inspection tasks, you should be able to coordinate your own work with the inspection tasks assigned by the general administration When needed by the General Administration, we should act vigorously and start with our backpacks Fifth, we should establish three kinds of righteousness First, adhere to the principle of righteousness Principle is big right and big wrong We can't trade with principle If we can't adhere to the principle, we can't be a qualified inspector The second is the integrity We should be fair and just, not moved by any interests, not by any personal feelings, and no one should be allowed to let go of water when greeting, otherwise, it will be a problem for us to be devoted to our duties Third, we should be honest and selfless We have done a good job in the data verification of drug clinical trials It is very important that our comrades in the verification center take the lead At the beginning, when they couldn't arrange the inspection sequence, they began to check from the hospital of their alma mater, which is called selflessness Sixth, we should stick to three bottom lines everything
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