The traditional Chinese medicine injectable preparation prescription is verified launched --All varieties should be built and supervised the file according to the lot number

The traditional Chinese medicine injectable preparation prescription is verified, launched --All varieties should be built and supervised the file according to the lot number
It is reported ' Reporter Wang LeMin) Before the end of this year, medicine supervises the department and carries on the verification of production technology and prescription to all traditional Chinese medicine injectable preparation variety that will be producing. Supervise the notice that the administration bureau sends out according to national food medicines on November 27, injectable preparation finished before the end of the year verifies and also includes all intravenous injectable preparation that is producing. It is reported on the basis of verifying in an all-round way, every injectable preparation of variety set up intact supervision file one by one according to the authentication code. The supervision file mainly includes the following contents: Current intact production technology and prescription, key production equipment, the crude drugs base is original and gather processing requirement, raw materials medicine, extract, crude drugs, adjuvants, bag material exposed to medicines directly supply the market conditions condition, the products quality criteria carried out actually, medicines manual and label, the bad reaction monitors the result, entrust production and process and examine the situation, all previous to produce and supervise inspection, quality inspecting the situation by random samples, verifying the working condition, risk assessment and verifying the conclusion, existing problem and result. The variety not verified that because stop production, should set up basic information file. It is introduced medicine supervise department will stop production, go on variety that verify, order variety that stop production to manufacturing enterprise or correct within a definite time period carry on key supervision after the verification yet. As requested, all resume production without authorization, produce, alter the production technology and enterprise that does not study and declare of the prescription according to the regulation again not according to craft and prescription after verification, will investigate and prosecute strictly in accordance with the law. The notice emphasizes, have already passed the injectable preparation variety verified before this to some province and city, especially traditional Chinese medicine injectable preparation variety, should put the variety in order and supervise file and relevant questions according to the new requirement, carry on pointed verification again if necessary, in order to get rid of the potential safety hazard, reduce the risk.

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