Traditional Chinese medicine parenteral solution frequently meets accident Torture the pharmaceutical factory GMP and authorize the true and false

Traditional Chinese medicine parenteral solution frequently meets accident Torture the pharmaceutical factory GMP and authorize the true and false
Author: Wen Xin [the intelligent clever network of pharmaceutical industry ] will be since 2009, parenteral solution will frequently meet accident, many kinds of medicines are let and stopped. In this numerous accidents, perhaps we can find some common points, look for the truth from generality, could avoid following the same old catastrophic road. The incident is reviewed February, the pharmacy of river has parenteral solution of a pair of the rhizome of Chinese goldthread and causes death in Usu, the producer stops production after the death by accident happened. Bureau of Drugs Supervision releases in two after the meeting finally, the expert thinks, though has not unusually found the checking of quality of medicines and production place at present, but the case taken place reflects syndrome in order to mainly behave with inflammation of whole body, clinical manifestation and transferring to having other sources to cause the etiology to enter the blood to brief to return on suddenly. Combine the clinical operating position, judge tentatively, the parenteral solution of a pair of the rhizome of Chinese goldthread of many lot number which pharmacy Co., Ltd. Jiamusi Branch of river produces presents high relevance with the bad incident that happens in Qinghai Province this time in Usu of Heilongjiang. 13 patients in Zhong Shan City of Guangdong Province are after using problem medicines that the medicine company of Tin Shui produce on March 19, clinical manifestation of the shiver with cold appears, generating heat etc.. And then examined, the hot original project of fragrant red parenteral solution of this lot number that the medicine company of Tin Shui produces is not up to standard. Ministry of Public Health releases the urgent notice on March 24, it is fragrant red parenteral solution of 080524 to require all types of medical organization to stop using the lot number that Zhejiang Tin Shui Pharmaceutcal Co., Ltd. produces immediately. On March 30, the original project of fever for Zhenbao Island of the notice of Bureau of Drugs Supervision of Hubei is not up to standard. Also in March, market Xinhua district hospital of Pingdingshan reflects: "The doctor of our academy finds the injection of production of pharmacy Co., Ltd. of Hill's health of water of Shandong Si by having bigger foreign matter in 0.9% sodium chloride parenteral solution while treating for the patient, we contacted numerous producers, 3 months passed by, but producer's attitude is tough, disregard slowly. " Look for the common one not up to standard first of all that we would rather have a look at fragrant red parenteral solution and easy blood of generality - -It is hot and original. It is hot to include the compositions of the bacterium, virus and fungi and other originally and cause the hot material. Medicines most common main heat to come from the intersection of leather and getting blue negative the intersection of bacterium and endotoxin of cell wall originally in the preparation. That is to say, the so-called one is hot and original, should generally come from the outside of medicines. And big foreign matter which Pingdingshan hospital sees comes from the outside naturally. In the question of the parenteral solution, we can see, the packing of product is ampoule bottles. According to pharmacy packaging facility manufacturer, what the producer needs the infrared course of washing the bottle in order to guarantee the ampoule after the wrapping enterprise has purchased the bottle is aseptic, then bottle the vacuum. So, theoretically, it is impossible to bring the hot original material into the ampoule bottle. And these enterprises are all the regular pharmaceutical factories, all authorize through GMP. And according to the general view, in the standardard management of quality of production of medicines (GMP) Under the condition, the view which can generally be accepted in quality control of production of medicines is: Exist the intersection of bacterium and endotoxin mean, store in hot and former. It is more impossible to present big foreign matter. Then in these a succession of incidents, which ring is not connected well? Pass GMP, it is really GoodManufacturePractice? A kind of very familiar cheating situations of industry personage are enterprise's environmental protection. Enterprises will all often consume a huge sum of money and build the sewage disposal apparatus, the apparatus -treated trade effluent can really reach the discharge standard. However, because the operating cost is too high, so, enterprises often turn on the apparatus when checking, let the apparatus be left unused on ordinary days, in order to save the operating cost. Predictably, the question of experience in environment protecting mode is often the question that other supervision departments meet too. Such as big infusion enterprises, GMP authorizes once every five years, whether can guarantee enterprises must be qualified in the middle of this? Set up, can't guarantee commitment of enterprise by a lot of threshold while being simple, how about can accomplish the name to return to in fact, it is a question very about to consider of supervision department. Alternatively put interests low a little, the conscience and what the responsibility is put being a little higher only, GMP can really contribute, medicines could be really safe too, become the strong weapon that the mankind opposes disease, keeps fit.

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