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

Quality control – specifications and tests
issues and was subsequently mailed out for public consultation. The comments
received were collated by the secretariat for submission to the Expert Committee.
It had been noted that the requirements of the monograph did not
necessarily apply to preparations that were intended for any use other than by
oral administration. It was pointed out that such non-oral preparations, for
example, vaginal or rectal capsules, might require a special formulation, method
of manufacture, or form of presentation appropriate to their particular use. Starch
capsules (often known as cachets) are also not included in the monograph.
The Expert Committee adopted the text as proposed.
3.4.2 Proposal for revision of general monographs: parenteral preparations
Following discussion at the May 2012 consultation, the draft general monograph
on parenteral preparations was circulated for public consultation. The comments
received were then collated by the secretariat in August and September 2012 in
preparation for consideration by the Expert Committee.
The proposed revisions of this general monograph were part of the review
of general monographs endorsed by the Expert Committee at its forty-second
meeting. Account was taken of recently adopted revised texts for 3.2 Test for
sterility, 3.4 Test for bacterial endotoxins, 5.6 Extractable volume and 5.7 Test
for particulate contamination.
One of the major changes proposed in the revision was the required
compliance of all parenteral preparations with tests for bacterial endotoxins
(or, where justified, pyrogens). Consequently, a review of the individual
monographs for injections is necessary, with the addition of a test and limit
for bacterial endotoxins to each monograph that currently does not include
such a requirement. It was noted that the requirements of the monograph
did not necessarily apply to human blood and products derived from human
blood, to immunological preparations, to peritoneal dialysis solutions or to
radiopharmaceutical preparations.
The Expert Committee proposed a number of changes to the draft and
adopted the monograph subject to the amendments proposed.
3.4.3 Proposal for revision of 5.1 Uniformity of
content for single-dose preparations
The preliminary draft of the revision of the chapter of The International
Pharmacopoeia on uniformity of content for single-dose preparations was
discussed at the consultation in May 2012. It was subsequently circulated for
public consultation. Comments received were collated by the secretariat prior to
the meeting of the Expert Committee.
The Expert Committee noted that it was proposed to revise the text to
bring it in line with the draft proposal for revision of the general monograph on
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