Future Directions for the AIM and EDA Concepts - Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products - page 396

12. The purpose of using AIM is twofold: (1) development/characterization and (2)
quality control. Do you plan to publish all the substantiating information, or
would it be up to each company to cross-validate to existing impactors?
Another participant indicated that stakeholders need to let things get tested
by time and experience. If it takes too long to get these ideas through to USP
and Ph. Eur., then each company should start cross-validating these methods
themselves. [Some of the results from this type of activity are presented in
Chap. 10 , and earlier in 2012, the Inhalanda Committee of the Ph. Eur. started
a new work initiative to develop validation data for AIM-based systems.]
13. Would AIM and EDA be mandatory or optional?
Dr. Tougas indicated on behalf of the panel that both concepts have been
thought of as alternative s [to current methods] in OIP QC testing, and as such
they are enhancements for development. The use of these or any other methods
is of course optional.
In this second part of the conference, the questions were responded to by the
panelists covering the topic “Pharmacopeial Perspectives on EDA and AIM—
European and US Viewpoints.”
14. We don't want to buy new equipment. We suggest that you publish the princi-
ples but not specify equipment in the Ph. Eur. and USP.
Some [abbreviated] apparatus(es) will need to be described in the pharma-
copeia, for regulatory purposes.
15. In the Ph. Eur., we have the twin impinger (apparatus A). We need to rethink the
utility of this apparatus. It has a role to play, because of the bouncing issues
with other cascade impactors.
This topic deserves consideration as a future development of the AIM con-
cept (see Chap. 10 ).
16. Why can't pharmacopeias write requirements for an apparatus, without speci-
fying the apparatus? For example, if the USP is moving toward QbD approaches,
why do we need to put apparatus description into USP?
[Dr. Steve Nichols]: Someone needs to be able to go and test the product.
Regulators need standard principles, stage cutoff sizes, validation information,
etc. Even now, the Ph. Eur. states that you can use ANY method as long as it's
validated. But there are legal reasons for describing a specifi c apparatus. To
change that requirement, at least in Europe, someone would need to change
the law. If there is enough interest, IPAC-RS and EPAG should develop a pro-
posal/monograph and send it to the Ph. Eur. Inhalanda Working Party for con-
sideration. And since the USP/EP harmonization takes 7 years on average, it
would be good to submit the proposed monograph to the USP and EP simulta-
neously. [The peer-reviewed journal attached to the Ph. Eur.] Pharmeuropa
can publish your proposal. If you do not come up with a monograph, the Ph.
Eur. Working Party will develop one, but the outcome may not be exactly what
you want to see. Someone also should compare the FPD (fi ne-particle dose
<5 m aerodynamic diameter metric in the Ph. Eur.) requirement with the

EDA approach.

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