“acanthopanax Event” There Are Many Questions Was Not Clear
Be exposed since early October the Fourth People’s Hospital of Yunnan Province, Heilongjiang Province, Wanda pharmaceutical use of Acanthopanax injection death occurred 3 serious adverse events, the entire community has been watching events development. November 6, the State Food and Drug Administration informed the serious adverse events Acanthopanax injection phased conclusion, this is not the adverse drug reaction, but with the pollution caused by the drugs of serious adverse events. This conclusion gives us Traditional Chinese medicine Injection safety hung in a heart put down, but drugs are still difficult to put aside concerns about supervision, some doubt remains in my mind did not answer.
First, after careful scrutiny of the pharmaceutical packaging can not be anti-bacterial.
According to the Food and Drug Administration briefing, Wandashan Pharmaceutical company part of Acanthopanax injection drugs in circulation was rain soaked, so that pharmaceutical contamination. July 1, Kunming, torrential rain caused stock Acanthopanax injection soaked by rain. Pharmaceutical and Biological Products, Yunnan Province, where the food and drug test drugs by the rain soaked parts of the sample soaked in drugs, but not all bacteria detected in a variety of.
This, the State Food and Drug Administration, the explanation given was that “in many years of heavy rainfall once in the case, the original conventional storage conditions did not meet the requirements, the rain soaked; there may be too heavy rain large, sewage can not be discharged in a short time in a timely manner; and public facilities led to soak for several reasons. while in other places, such as checking the Wandashan Pharmaceutical in Heilongjiang Province produced Acanthopanax injection is sterile. This explained, “Acanthopanax injection event” is “water immersion” relevant.
But we know that infusion Preparation By intravenous drip directly enter the human blood system and the role of large volume injection, the infusion Preparation Bacteria, pyrogen, particulate control, and high purity of the strict quality requirements, so our country on its complement of medical packaging materials such as glass bottles, aluminum cap, infusion stoppers and others have strict requirements. Therefore, the rubber seal of the infusion Sega aluminum cap, bottle must be completely sealed. The problem was detected bacterial drugs, the narrative of packing sealing may be a problem, the use of these packages is the result of drug packaging after the examination and approval of scientific assessment.
Said experts are further analysis, is what causes Acanthopanax injection will be closed after the bacteria enter. There may be reasons for long-distance transport, etc., are complex.
Second, the replacement of packaging labels, whether corporate behavior rather than personal behavior?
Food and Drug Administration reported that the rain soaked Acanthopanax injection is Wandashan Pharmaceutical sales network of sales personnel in Yunnan Zhang transferred from Wandashan Pharmaceutical packaging labels, replacement sales.
Statement under the Food and Drug Administration, the Drug Administration Law, drug labeling regulations, Good Manufacturing Practices (GMP) of these provisions, on the labels, instructions and packaging requirements are strict, factory is absolutely not allowed to be replaced after . Because each has a strict record label, use the number, release number, the number of recovery, even damage the labels are to be recovered, this is the most fundamental means to ensure drug quality and requirements. Meanwhile, the pharmaceutical distribution regulatory approach also clear that the packaging is not complete, batch number is not clear, the sales staff in the acceptance of the right to return when the manufacturer. Quality problems of drug products, must suspend sale and use. Even without the pollution, does not allow replacement of labels, packaging and instructions. Random replacement of labels, packaging and manual acts are serious violations of the Drug Administration Law of China, drug labeling the relevant provisions of the law is illegal.
Therefore, in accordance with the routine, as sales of Zhang soaked by the rain should bring back injection drug manufacturer, were destroyed by the drug manufacturer, and Zhang has not returned to the rain soaked the drugs, but braved the law risk, took the trouble to transfer from the company to package labels, and replacement of packaging labels and instructions, which he has any good? In addition, Zhang also not one to complete the process, he reports to pharmaceutical companies the situation, to allow him to do was nod, he was granted the required labeling, packaging and instructions.
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