18 February 2020
GMP News No. 832
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: