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full chemical testing for drug excipient

Question asked by Meng Xu on Oct 6, 2010

I have a question regarding full chemical testing for drug excipient in pharmaceutical industry.


FDA requires a minimum of three lots of drug excipients to have full testing per USP. After three lots of full chemical testings are met, is identification analysis being performed only upon receipt? How do you make that switch? How often do you perform full chemical testing for drug excipient, once a year, once every two years?


Anyone who works in pharmaceutical industry or who have experiences in this field mind share that information or give me some suggestion?

Thanks!

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