WHO Technical Report Series, No. 981 - World Health Organization

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
Pharmacopoeia. In agreement with selected experts, the secretariat decided to
postpone the provisional release of pentamidine isetionate ICRS 1.
The Expert Committee adopted the ICRS subject to clarification of the
differences and to confirmation that the recorded IR spectrum corresponds to
pentamidine isetionate.
In addition, EDQM had established the IIRS on proguanil hydrochloride.
The Expert Committee took note of this action.
4.1.4 Supplementary information section of The International
Pharmacopoeia: 4. Reference substances and reference spectra
The document on reference substances and reference spectra was initially
submitted to the consultation in May 2012. The draft was circulated for
comment in June 2012 and the comments were collated in August 2012. The
document describes principles to be applied during the establishment and use
of ICRS in order to guarantee that the reference substances are suitable for
their intended purpose. The document is not applicable to WHO International
Biological Reference Preparations. The proposed chapter would be part of the
supplementary information section of The International Pharmacopoeia, which
provides the user with texts for guidance and information, and will not constitute
part of the standards.
WHO Technical Report Series, No. 981, 2013
4.1.5 New release procedure for International Chemical Reference Substances
At its forty-fifth meeting, the Expert Committee agreed on a new release
procedure for ICRS. 1 On the basis of this procedure, case-reports issued by EDQM
after analytical testing of candidate material were reviewed by the secretariat
with assistance from collaborating laboratories. If the testing was performed
according to the General guidelines for the establishment, maintenance and
distribution of chemical reference substances and the candidate material was found
suitable, the secretariat, in collaboration with the collaborating laboratories,
released the ICRS provisionally. In accordance with the rules, the case-reports
were subsequently submitted to the Expert Committee at its next meeting
for final adoption. After provisional release, EDQM begins the distribution of
these ICRS.
This process expedited the release of ICRS and enabled WHO to
react more quickly to urgent demands for reference substances. However, the
procedure did not clearly allocate the accountability for the release of ICRS to a
single person or body. The Expert Committee discussed the issue and agreed on
the following amendment to the new procedure:
1
See Annex 1, WHO Technical Report Series, No. 961, 2011.
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