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    Home > Active Ingredient News > Drugs Articles > Pharmaceutical cold chain standard formulation started

    Pharmaceutical cold chain standard formulation started

    • Last Update: 2013-09-05
    • Source: Internet
    • Author: User
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    Source: International Business Daily on September 5, 2013, 9 drug distribution enterprises, including China Pharmaceutical Business Association United Nations pharmaceutical Holding Co., Ltd., kyushutong, China Resources Pharmaceutical Co., Ltd and Harbin Pharmaceutical Group, set up a temperature sensitive drug distribution safety laboratory (hereinafter referred to as the "laboratory"), and plans to formulate the pharmaceutical cold chain standard within 3 years According to the plan, the laboratory will enter the test phase from 2014, with a period of one year In 2015, it will be the standard formulation and verification phase, and the achievement appraisal will be completed in the first half of 2016 As we all know, the safety of medicine is directly related to people's livelihood and social stability The circulation safety of refrigerated drugs, especially temperature sensitive drugs, is an important part of drug safety However, at present, the cold chain of medicine in China is very imperfect According to some data, at present, the coverage capacity of cold chain of Chinese drugs is about 10% According to the statistics of drug quality problems found by drug regulatory authorities, nearly 20% are related to cold chain, including problems in warehousing, storage, transportation, etc The development of pharmaceutical cold chain is imminent Fu Mingzhong, executive chairman of China Pharmaceutical Business Association, said that in accordance with the requirements of the 12th Five Year Plan for national drug safety, GSP will be revised in 2012 Relevant regulations are implemented The laboratory will take scientific and effective tests to ensure the safety of temperature sensitive drugs in the circulation process, and provide rigorous and reliable real data and basis for the improvement of standards It is of great significance to improve the management level of drug circulation industry and ensure the safety of drug use for the people Fu Mingzhong said that the key to implementing the circulation safety of temperature sensitive drugs is that all relevant units and enterprises in the circulation supply chain of such drugs can accurately understand and control the influencing factors, control the operation links, and have qualified hardware equipment system and software system as guarantee to jointly build a safe supply chain in the whole process of circulation of temperature sensitive drugs The reporter learned that according to the guidance of the government drug regulatory department, the laboratory determined the test category as the most sensitive type of drugs within the temperature range of 2 ℃ ~ 8 ℃ There were 27 pharmaceutical enterprises involved in the experiment, and 111 drug varieties were involved As a member of the laboratory, the head of Sinopharm said that as a leading enterprise, Sinopharm would actively participate in and complete the task, and work together with members to discuss the strategy of pharmaceutical cold chain Novo Nordisk also welcomed the establishment of the laboratory and called for the establishment of a professional and unified cold chain standard for medicine as soon as possible.
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