SST Corporation's Quarterly Electronic Newsletter

At a Fall '05 SOCMA API Conference, SST's Executive Director of Technical Affairs, Dr. Arthur Fabian, gave a presentation entitled, "Brainstorming BACPAC II". The latter is Guidance on Post Approval Change in the last synthetic step that FDA has drafted but not issued.

In his presentation, Dr. Fabian characterized several Industry Trade Group proposals as "Good News / Bad News." Although not all Process Changes required the filing of a Pre-approval Supplement (PAS), he maintained that too many Process Changes still did. Further, the scope of these proposals did not include changes occurring after the final filtration of the API, such as drying, micronizing and packaging.

He then offered two novel approaches to the subject, one "phased" and the other "holistic." The former expanded the scope of the Trade Group proposals and the latter combined BACPAC I (Guidance for earlier steps) with his thoughts on BACPAC II. In both approaches, the PAS filing mechanism was used sparingly, ie, only when the API was actually impacted and the data to demonstrate equivalence of pre vs. post change material were more extensive than a straightforward specification comparison.

It is noteworthy that FDA arrived at exactly the same conclusion re-issuing a combined BACPAC I and II and informed Industry at a Berlin API Conference held the very same day as Dr. Fabian's presentation!

For more information on the details of Dr. Fabian's presentation, please see the January '05 Gold Sheets or contact him directly at afabian@sst-corp.com.









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At a Fall '05 SOCMA API Conference, SST's Executive Director of Technical Affairs, Dr. Arthur Fabian, gave a presentation entitled, "Brainstorming BACPAC II". The latter is Guidance on Post Approval Change in the last synthetic step that FDA has drafted but not issued. In his presentation, Dr. Fabian characterized several Industry Trade Group proposals as "Good News / Bad News." Although not all Process Changes required the filing of a Pre-approval Supplement (PAS), he maintained that too many Process Changes still did. Further, the scope of these proposals did not include changes occurring after the final filtration of the API, such as drying, micronizing and packaging. He then offered two novel approaches to the subject, one "phased" and the other "holistic." The former expanded the scope of the Trade Group proposals and the latter combined BACPAC I (Guidance for earlier steps) with his thoughts on BACPAC II. In both approaches, the PAS filing mechanism was used sparingly, ie, only when the API was actually impacted and the data to demonstrate equivalence of pre vs. post change material were more extensive than a straightforward specification comparison. It is noteworthy that FDA arrived at exactly the same conclusion re-issuing a combined BACPAC I and II and informed Industry at a Berlin API Conference held the very same day as Dr. Fabian's presentation! For more information on the details of Dr. Fabian's presentation, please see the January '05 Gold Sheets or contact him directly at afabian@sst-corp.com.


	SST representatives travel regularly in North America, Europe and Asia. Contact us to arrange a meeting in your region.

		SST Corporation welcomes Vincent Durante.
	Mr. Durante is an industry veteran for over 25 years, having spent most of his career importing and distributing active pharmaceutical ingredients with expertise in manufacturing, marketing, and health & beauty aids.


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