Significance of USP General Chapters above <999> for FDA

GMP News No. 832

GMP News
8 November 2006

Significance of USP General Chapters above <999> for FDA

Only few users of the USP know that there is a difference between the General Chapters with numbers below <999> and those above <999>. The corresponding statement can be found in the USP's General Notices. The text says that a General Chapter with a number below <1000> is mandatory, whereas General Chapters with numbers above <1000> are considered interpretations and thus do not represent official standards and binding requirements.

A question on this subject was submitted to the FDA. In a Q&A forum on current GMP questions, the FDA answered the questions whether USP General Chapters above <999> were equivalent to FDA guidances, which purpose these General Chapters have and how they should be used by manufacturers of medicinal products. On 4 October, the FDA published the answer in the Q&A forum.

The pharmacopoeial requirements are one of the topics of the education course
Quality Control of Raw Materials
in Vienna, Austria, on 30-31 January 2007.
Dr Günter Brendelberger
On behalf of ECA

The answers by Richard Friedman and Jon Clark from FDA's CDER can be found here:

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