|
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.
|
