Acceptance of Near Infrared Spectroscopy (NIRS) by the Regulatory Authorities

GMP News No. 139

GMP News
10 October 2001

 Acceptance of Near Infrared Spectroscopy (NIRS) by the Regulatory Authorities

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

Dr Günter Brendelberger


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