Draft General Chapter USP <1226> Verification of Compendial Methods Completely Revised

GMP News No. 824

GMP News
24 October 2006
 

Draft General Chapter USP <1226> Verification of Compendial Methods Completely Revised

 
The Pharmacopeial Forum 31, No. 2 of March/April 2005 included a suggestion for a new USP Chapter <1226> on the verification of compendial test procedures. In that version, the suggested scope of verification seemed to be quite broad.

Now, a completely revised version of this chapter taking account of industry's comments was presented in the Pharmacopoeial Forum Vol 32, No.4 of July/ August 2006. The two former tables with concrete requirements on the verification were deleted. Instead, there is only a general description of the verification process. Now it is up to the user to decide which validation parameters he/she would like to check in order to prove that the pharmacopoeial method can be carried out in his/her laboratory.

The text makes it clear that these recommendations are not intended for analytical methods that have already been implemented in the laboratory successfully.
  

The pharmacopoeial requirements as well as the Draft General Chapter <1226> will be dealt with in detail during the GMP Education Course "Quality Control of Raw Materials" to be held in Vienna on 30-31 January 2007.

 
Author:
Dr Günter Brendelberger
On behalf of ECA
  

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