ECA's Survey on RMMs has shown that many pharmaceutical companies are
interested in using alternative microbial methods for non-release tests
like e.g. environmental monitoring or quality control of water.
In the Q&A Sections of the EMEA Quality Working Party (QWP) website
the following question was raised which relates to the topic:
What is the regulatory consequence of implementing an alternative
method for rapid control of microbiological quality of WFI and Purified
water?
"According to EU legislation, pharmaceutical manufacturers are
required to use European Pharmacopoeial standard water in the manufacture
of medicinal products.
The European Pharmacopoeia (Ph.Eur.) has recently introduced a chapter
making reference to the acceptability of rapid microbial methods to
replace the standard Pharmacopoeial methods provided appropriate
validation has been performed.
Following discussions at QWP and the ad hoc GMP inspector's group, it
is suggested that the introduction of such methods might require specific
review to ensure that the appropriate validation steps have been followed
and that the water continues to meet the Ph.Eur. specifications. Since, in
the case of water, the validation will not be product specific, it is
suggested that a company could request the Supervisory Authority to carry
out a specific site inspection. The performance of such an inspection
would be at the discretion of the Supervisory Authority and could involve
a pharmaceutical assessor where necessary.
Since it is expected that the water will continue to meet Ph.Eur.
specification, if tested, no change to dossier requirements*
(variations) would be involved and therefore no regulatory impact on
individual products would normally be anticipated.
*This will depend on the level of detail in the original dossiers
concerned"
There are some interesting aspects in the QWP answer:
EMEA is aware of the new EP Chapter 5.1.6. That is good.
QWP proposes a "specific" site inspection by the local
competent authority in the case of using an alternative method. That is
additional work.
The implementation of an alternative method for water testing does not
provoke a change to the dossier depending on the level of detail in the
original dossiers. Once again, this statement teaches us to be very
careful with the information we add to the dossier. If the level of detail
is too high, modifications of these presettings are very much restricted.
The last statement is the important one. It shows a way how the
industry could move forward and gain more experience with RMMs without the
high costs and the long approval process of a Type II variation.
It seems that in this certain case the requirements of EMEA and the
wishes of the pharmaceutical industry have a lot in common.
Nevertheless, it leaves the challenges of introducing RMMs for release
testing unsolved. At this moment it remains a type II variation in Europe
– with all its consequences.
|
