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Pharmacopoeial Methods
Posted: Fri Mar 08, 2013 3:16 am
by shadow
It is my understanding that if using a pharmacopeia method in a cGMP environment it is enough to verify the method and there is no need to validate the method, was I advice correctly? The methods used to test raw materials are all from pharmacopeia and these raw material are used for manufacturing, do we need to validate the methods? Please advice
Re: Pharmacopoeial Methods
Posted: Fri Mar 08, 2013 9:11 am
by scottythree
You are referencing USP <1226> Verification of Compendial Procedures. A quick Google search should help.
Re: Pharmacopoeial Methods
Posted: Tue Mar 12, 2013 5:29 pm
by shadow
thank you!
Re: Pharmacopoeial Methods
Posted: Tue Apr 02, 2013 9:03 pm
by krickos
Just do not miss the detail that you have to document that you have verified that it is suiteble for the intended use.
Re: Pharmacopoeial Methods
Posted: Wed Apr 03, 2013 8:40 pm
by shadow
Thank you Krikos