Today, Near Infrared Spectroscopy (NIRS) is often used in the
pharmaceutical industry in order to comply with the European GMP
requirement that the identity of each batch of a starting material be checked.
By means of the monograph in the European pharmacopoeia, NIRS has for the
first time been described officially, which led to a higher acceptance
with other authorities. At the International NIRS Conference of the
University of Heidelberg in co-operation with CONCEPT HEIDELBERG, Dr Roger
Alexander of MCA, the British regulatory and supervisory authority,
presented a list which documents that MCA has accepted NIRS in a
considerable number of marketing authorisation approvals for finished medicinal
products:
-
for identity tests (more than 100
authorisations)
-
for content determination (approx. 20-30 authorisations)
-
for moisture determination (approx. 20-30
authorisations).
Furthermore, a survey among the EU regulatory
authorities showed that the acceptance of a NIRS method in an application is possible or
at least thinkable for all member states. A big disadvantage of NIRS from
the point of view of the supervisory authorities lies in the fact that the
official control laboratories cannot simply repeat this method, which is
actually required by law, since NIRS is an 'indirect method'.
Besides, the guideline of PASG
(Pharmaceutical Analytical Science Group), which contains among others
information on the qualification of NIRS instruments, should be of great
interest to all those who apply Near InfraRed Spectroscopy. You will find
this guideline on the internet at www.pasg.org.uk.
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
|
