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how does your state monitor the medicine quality ?
Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.
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how to assure the quality of the medicine your country ?i guess there must be some goverment lab analysising the sample sent by pharmacy or the hospital .and how does the lab run ?
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German Ringversuche (round robin):
http://www.r-concept.de/Ringversuche/ringversuche.html
http://www.instandev.de/ringversuche/
http://www.r-concept.de/Ringversuche/ringversuche.html
http://www.instandev.de/ringversuche/
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Good question! The FDA does not "do" anything, she regulates. The pharmaceutical industry itself assures that the quality of its products is sufficient.
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Well, not entirely true, Uwe. A quick search of PubMed showed at least 61 publications by FDA scientists to date in 2009, including at least one method intended to be used to assure the quality of pharmacy-compounded drug mixtures. There are 70 pubs just by CDER scientists (some overlap with the first 61 pubs, but obviously some additional ones). And I'm pretty sure there is FDA oversight of the pharmaceutical industry's oversight of itself...The FDA does not "do" anything...
All standard disclaimers apply. My posts are my opinions only and do not necessarily reflect the policies of my employer.
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Mary: The way I read the question posted above: who does the QC of pharmaceuticals, and where is this analysis done? It is done in the quality control department of the drug manufacturers.
The FDA oversees and checks such activities, but this was not the question.
I did NOT mean to say that there is no activity at the FDA. I am sorry for bad use of the language if my post was misunderstood this way.
The FDA oversees and checks such activities, but this was not the question.
I did NOT mean to say that there is no activity at the FDA. I am sorry for bad use of the language if my post was misunderstood this way.
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thanks for all of your reply ,and i would tell all of the responsibilities and activities of our country as belows
first :there will be one laboratory in every city .such as in beijing there will be one ,and even in the remote districts .there will be also one laboratory . except for the city .and there will be every lab in every province .the lab is runned by government .and certainly all of the emplyee is employment by government .maybe 50--60 person in every city lab .
secondly ,the major task for the lab is export the report of medicine to the checking officer .they went to the pharmacy ,pharmaceutical company ,hospital and institute which involve medicines .and they check randomly ,and send the sample to the lab .then if there were some medicines with quality problems ,they can punish the manager of the enterprise .this is the routine check .
thirdly ,the upper rank government will run several aimed check ,it called
special project .then we do analysis for these medicine .
i heard of that in EU or US,even other countried ,there were not so many lab running by government .maybe the tax payer wont agree .
first :there will be one laboratory in every city .such as in beijing there will be one ,and even in the remote districts .there will be also one laboratory . except for the city .and there will be every lab in every province .the lab is runned by government .and certainly all of the emplyee is employment by government .maybe 50--60 person in every city lab .
secondly ,the major task for the lab is export the report of medicine to the checking officer .they went to the pharmacy ,pharmaceutical company ,hospital and institute which involve medicines .and they check randomly ,and send the sample to the lab .then if there were some medicines with quality problems ,they can punish the manager of the enterprise .this is the routine check .
thirdly ,the upper rank government will run several aimed check ,it called
special project .then we do analysis for these medicine .
i heard of that in EU or US,even other countried ,there were not so many lab running by government .maybe the tax payer wont agree .
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