IPQ’s October Monthly Update takes a hard look at the current state of pharmaceutical manufacturing and regulation – where the problems lie and what the most knowledgeable of the industry and regulator participants in the global dialogue view as the path to move forward.
The international section of the issue begins with a review of a keynote presentation given by pharma quality and operations veteran Neil Wilkinson at a recent PDA/FDA workshop on ICH Q10. The Expert Working Group member explored industry’s past and current manufacturing and control performance, the regulatory environment it has been operating in, and the role the quality systems concepts in Q10 can play in addressing the shortcomings and strengthening quality cultures and operational excellence.
A second story explores the ideas presented at a session of DIA’s annual meeting on addressing the global problem of manufacturing changes by former FDA and now GSK CMC leader Moheb Nasr and by the agency’s Christine Moore and EMA’s Emer Cooke. Nasr reaffirmed his belief that agreement around the control strategy expectations in applications holds the key to a more continuous improvement-friendly regulatory process. Moore and Cooke also highlighted the need for a global approach to regulating manufacturing changes and offered their ideas on the pathway forward.
The October Monthly Update also continues IPQ’s analysis of the multifaceted FDA Safety and Innovation Act (FDASIA) and the significant impact it will have on the agency’s CMC review and inspection processes. The July/August and September issues dealt with the implications of the new generic drug and biosimilar user fee components of FDASIA on both the review and inspection fronts. This issue focuses on other components of the new law that will also reverberate through the quality regulatory arena.
The first story analyzes the important new tools in FDASIA’s Title VII to help the agency address the challenges of regulating a global supply chain. The story also takes a look at other supply chain regulatory tools in Title X of FDASIA designed to attack the problem of drug shortages, in particular, and in the just-passed “Safe Doses Act” to deal with the significant problem of warehouse and cargo theft.
In the second story, IPQ turns attention to the CMC and GMP implications of the catch-all Title XI of FDASIA. A new system for registering medical gases and FDA participation in standard setting for nanoparticle-containing products are among the more than two dozen areas of concern the Title encompasses.
The October issue also addresses the release by FDA’s generics office of a draft stability guidance. The new draft harmonizes the expectations for generics with the ICH international standards being applied to new drugs in the US and marks another step in the renovation of OGD’s review process.
Also covered in the issue are the upgrades FDA is pursuing to its field alert reporting system to strengthen this important link in the communication chain on where quality systems are falling short and products have emerged at risk to the public.
The latter two stories are updates on recent in-depth coverage IPQ has given to the generic stability and FARS issues, and the linkages to those stories are highlighted.
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