Another 16 batches of drugs were unqualified, and 12 batches were Chinese herbal pieces

Shanghai Drug Administration, 2018, No.1 drug supervision sampling quality notice (December 6, 2018), 2018, No.2 In order to strengthen the quality supervision and management of drugs and drug packaging materials, standardize the market order, and ensure the quality and safety of listed drugs and drug packaging materials, Shanghai Drug Administration has implemented the quality supervision and sampling inspection on the production, operation and use units of drugs and drug packaging materials in this city, and now the unqualified products are announced (see the attached table) Shanghai Drug Administration has organized relevant regulatory departments to investigate and deal with unqualified products according to law and take control measures, requiring relevant units to suspend sales and use, recall relevant products and make rectification according to risks Shanghai Drug Administration will further strengthen the follow-up inspection and sampling inspection of the unqualified products and the corresponding enterprises, and require the local market supervision bureau to strengthen the daily supervision, urge the enterprises to find out the causes, formulate and implement the rectification measures, and eliminate the potential risks It is hereby announced Attached table: 1 Unqualified situation of drug supervision spot check (circulation and use spot check) 2 Unqualified situation of drug supervision spot check (production spot check) tips of Shanghai Drug Administration on December 5, 2018 (disclosure scope: active disclosure): The inspection items in drug standards include test methods and limits, homogeneity and purity, etc which reflect the safety and effectiveness of drugs Character refers to the physical characteristics or appearance shape of a drug Unqualified character may affect the quality and efficacy of a drug Processing refers to the processing of Chinese herbal medicines into pieces by means of baking, canning, frying, washing, soaking, bleaching, steaming, boiling, etc The purpose is to eliminate or reduce the toxicity of drugs, strengthen the curative effect, facilitate the preparation and storage, and make the drugs pure Water content refers to the water content of the drug The high moisture content is usually affected by the packaging or storage environment of drugs, which is caused by moisture during storage and circulation Content determination refers to the physical, chemical or biological methods to detect the relevant components contained in the test article Extract determination refers to the determination of soluble substances in medicinal materials and pieces of Decoction with water or other suitable solvents Disintegration time limit refers to the limit of time required for solid preparation to check all disintegration, dissolution or fragmentation and pass through the screen in the specified medium by the specified method Related substances refer to the impurities that may be contained or produced during the production and normal storage of drugs according to the established process and need to be controlled PH value is a method to determine the activity of hydrogen ion in the aqueous solution of drugs, which generally refers to the degree of acid-base property of drug solutions Attached table 1 unqualified situation of drug supervision sampling (circulation and use) attached table 2 unqualified situation of drug supervision sampling (production)