Saturday, June 20, 2009

Quality control — specifications and tests

2.1 The international pharmacopoeia — 50 years on
The Committee confirmed that publication of The international pharmacopoeia
(4) continued to fulfil a need in developing countries by
providing less technically advanced tests for specific substances and
preparations. The usefulness of monographs for finished products was
also confirmed.
The Committee discussed the merits of introducing modern analytical
techniques. It was recognized that such new techniques could sometimes
be more sensitive, rapid and robust, as well as potentially less
expensive. However, there was still a need for less advanced methods.
It was proposed that information on both types of methods might
be provided in parallel, with the newer techniques indicated as the
first choice and the less advanced methods as alternatives. Thus,
where resources permitted, the more technically advanced methods
should be used. However, the possibility of using the less advanced
alternative methods to check compliance with pharmacopoeial
specifications, where necessary, would increase the usefulness of The
international pharmacopoeia. In making these proposals, the Committee
emphasized the importance of compliance with pharmacopoeial
requirements as part of the overall strategy for detecting
counterfeit and substandard products (5). The introduction of alternative
methods would require careful presentation, and it was recommended
that a statement should be inserted in Volume 5 of The
international pharmacopoeia to introduce the concept, together with
the use of appropriate headings. This would reiterate that implementation
of The international pharmacopoeia was the responsibility of
national drug authorities.
2.2 Monographs for The international pharmacopoeia
The Committee was pleased to note that a number of additional
monographs for drug substances, pharmaceutical preparations (e.g.
tablets) and excipients are nearing completion for inclusion in The
international pharmacopoeia. It approved the inclusion of monographs
for antimalarials in Volume 5 of The international pharmacopoeia,
which is currently in press.
2.3 Dissolution test requirements for individual monographs
The Committee was informed that the WHO collaborating centres
were assisting with proposals on work in establishing dissolution requirements,
test conditions and acceptance criteria (limits) for certain
monographs. The Committee supported the concept of cooperation
with the International Pharmaceutical Federation (FIP) in hands-on
courses on dissolution testing. It is envisaged that WHO collaborating
centres might provide a venue for such courses and that attendance
would be open to participants from national control laboratories and
the pharmaceutical industry.
2.4 Basic tests for pharmaceutical substances and dosage forms
The Committee was informed of progress in the development of basic
tests, and verification by the collaborating laboratories. So far, three
volumes (Basic tests for pharmaceutical substances, Basic tests for
pharmaceutical dosage forms and Basic tests for drugs: pharmaceutical
substances, medicinal plant materials and dosage forms (6–8)) have
been published. These volumes now include 345 basic tests for substances,
208 for dosage forms and four for medicinal plant materials.
The next volume will be made available once a sufficient number of
tests have been developed and verified.
The need for four verifications of each test for dosage forms as
currently applied according to Annex 6 of the Committee’s twentyninth
report (9) was discussed. The possibility of accepting three
verifications was suggested, provided that there were no significant
differences between the results. The use of additional laboratories,
and encouraging feedback from those using the tests, was advocated.

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