In order to strengthen drug quality supervision and ensure the safety of public drug use, according to the annual sampling work plan of the provincial drug regulatory bureau, the provincial bureau has carried out spot checks and inspections on the quality of drugs produced, operated and used by the units, and now the spot checks found that the non-compliant drug situation is notified as follows: First, after verification and confirmation, marked 12 production enterprises (preparation units) a total of 13 varieties of 15 batches of drugs, after sampling does not meet the standards.
2. The relevant drug regulatory department has taken control measures such as seizure, seizure, suspension of sales and product recall of non-compliant products, and shall, in accordance with relevant laws and regulations, seriously investigate and punish the relevant production enterprises (preparation units) and sampled units in accordance with the law, and may inquire about the website of the relevant municipal market supervision authority.
, for non-compliant products and corresponding production and operation enterprises and units, the relevant drug regulatory departments should strengthen supervision, urge them to identify the causes of the problems, formulate and implement corrective measures, and effectively eliminate hidden risks.
the characteristics of the drug, such as appearance, odor, taste, solubility and physical constants are recorded under the characteristics of non-conforming items I and traits, to a certain extent, reflecting the quality characteristics of the drug.
chinese medicine drink tablets do not meet the requirements, may involve the following situations: the herbal medicine species deviation, the concoction process is defective, improper storage and so on.
, the purpose of total ash determination is to detect the purity of Chinese medicine.
, content determination refers to the use of prescribed test methods to determine the content of active ingredients in raw materials and preparations, generally can be used chemical, instrument or biometric methods.
content determination is related to the efficacy of the drug.
, identification is mainly used to identify and study the authenticity, safety and effectiveness of drugs.
according to the characteristics of different drugs, including empirical identification, micro-identification and physical and chemical identification, physical and chemical identification includes physical, chemical, spectral, chromatography and other identification methods.
: List of non-conforming drugs Original title: a batch of drugs unqualified (attached list)