Shandong Drug Administration issued drug quality sampling results 12 pharmaceutical companies were announced (attached list)

On December 8, Shandong Provincial Drug Administration issued the 7th issue of 2020 drug quality sampling announcement, 15 batches of drugs were found to be unqualified.
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 on drug quality inspection of drug production, operation and use 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 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.
3. For non-compliant products and corresponding production and operation enterprises and units, the relevant drug regulatory departments shall strengthen supervision, urge them to identify the causes of the problems, formulate and implement corrective measures, and effectively eliminate hidden risks.
the appearance, odor, taste, solubility and physical constants recorded under the characteristics of non-conforming items, etc., to a certain extent reflect 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 the total ash determination is to test 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)