|
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. Author:
Dr Günter Brendelberger
On behalf of ECA
The answers by Richard Friedman and Jon Clark from
FDA's CDER can be found here:
http://www.fda.gov/cder/guidance/cGMPs/general.htm
|
