Ji'nan's 25 essential drug manufacturers sign a pledge on quality and safety
9 day, 25 enterprises producing basic drugs in Ji'nan and Ji'nan Municipal Food and Drug Administration signed a commitment to the quality and safety of basic drug production, committed to the overall implementation of the system of quality authorized persons, to ensure the safety and reliability of the basic drugs, and to exist. Timely recall of essential drugs with hidden dangers is required.
after preliminary understanding, there are 25 enterprises producing essential medicines in Ji'nan, involving 252 essential drugs. The responsible person of the Municipal Food and Drug Administration told the reporter that the newly revised GMP will be promulgated and implemented in the first half of the year. In order to ensure the quality of the basic drug production, the new enterprises, the basic drug production enterprises and the production enterprises of the injections should be taken the lead in the implementation. Not only that, the drug regulatory department will also carry out electronic supervision of the anti microbial drugs and injections of basic drugs, implement the methods and means of non on-site supervision to the production enterprises, verify the basic drug production process prescriptions, and establish the regulatory files.
Ji'nan requires basic drug production enterprises to implement electronic management systems, conduct self-examination of prescriptions and processes, organize the production of basic drugs in strict accordance with approved prescriptions, processes and GMP requirements, audit all raw materials suppliers, strictly inspect and keep samples according to regulations, and strictly entrust basic drugs to processing. The management of entrustment inspection, which requires processing and entrusting inspection, must handle examination and approval procedures; close attention to related information on the detection and safety of adverse drug reactions and timely analysis, processing and reporting, and strengthening risk control.
in addition, in order to ensure the timely, full and quality supply of basic drugs, the drug supervision department of Ji'nan will also strictly examine the qualification of the basic drug delivery enterprises this year, establish the supervision files of the distribution enterprises, strengthen the supervision and inspection of the storage and transportation items of the basic drug delivery enterprises, and pay close attention to the transition. Period (3-9 months) basic drug delivery situation, the implementation of the whole variety of electronic supervision of the basic drug catalogue in the whole city, focusing on promoting the online monitoring of drug wholesale and retail chain enterprises, and improving the drug safety traceability system.