2005D-0021 International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
FDA Comment Number : EC4
Submitter : Mr. Mark Goldman Date & Time: 05/02/2005 05:05:15
Organization : Bayer Healthcare, Bioogical Products Division
Category : Drug Industry
Issue Areas/Comments
In view of the real benefits alluded to in terms of added flexibility to manufacturer's and regulators afforded by an enhanced knowledge of product and process characteristics derived from newer analytical methods and tools (page 2):
Given that there are different administrative procedures and classification schemes for post-approval changes between the areas, how can this benefit be harmonized? Will there be concordance between the participating bodies on specific classes of changes that can fall under this scheme and how can this be realized?
In view of the particular concerns around scalability of biological products, emphasis should be placed studies throughout the development cycle that can define the process scalability.
Likewise, for processes that will include biological materials with potential for adventitious infection risk, emphasis should be placed, begining with early stage studies, on the establishment of the clearance capacity of the process and the integration of this knowledge into risk-based decision making on further process development.
Guidance points addressing the relationship between a manufacturer's risk management program and risk-based knowledge base on the one hand and regulatory authorities risk-based inspection programs on the other, would be very helpful