The first story in IPQ’s Monthly Update for September explores FDA’s “New Inspection Protocol Pilot” (NIPP), which has significant implications for the way agency pharmaceutical pre-approval, surveillance and for-cause inspections will be planned, conducted, reported on, and assessed going forward. At the PDA/FDA conference in late September, OPQ’s David Doleski provided the first full public airing of the project and how it fits into the larger quality regulatory paradigm shift the agency is working to accomplish.
Through NIPP, CDER and the field force are working together to broaden the inspection process from a GMP compliance-only focus to one more capable of assessing the overall health of the firm’s quality management system and fostering continuous improvement – and potentially to one that can provide a vehicle for international inspection harmonization and enhanced inter-agency communication in line with the ICH Q8-12 guideline series.
During September, IPQ continued its focus on the rich dialogue around quality metrics that has been generated by the FDA metrics initiative and how the new draft guidance emerging from the agency pipeline in late July has impacted it.
In late August, FDA provided industry the opportunity to offer its initial feedback on the draft at a meeting at the agency’s headquarters. The third in IPQ’s recent series of metrics stories provides an in-depth analysis of the thoughts, concerns and suggestions that emerged as ISPE, PDA, PhRMA, GHPA, and IPEC and others engaged with CDER officials on the role that the FDA metrics initiative can play in helping advance the quality regulatory process and how it can most effectively play it. The feedback provided at the meeting gives a pretty clear picture of the main themes that will be fleshed out in additional detail in the forthcoming written comments on the draft guidance.
CDER Director Janet Woodcock has been stressing that the dialogue and benchmarking around the role of metrics and culture stimulated by the agency initiative may ultimately be more valuable and impactful in advancing industry’s quality management processes than the agency’s reporting program itself. One could feel that potential unfolding in the sharings at the August meeting, as the IPQ coverage tries to capture.
The two stories in the international section delve into the issues around site transfers – a key component in the manufacturing change equation.
At the CMC Strategy Forum in Brazil that CASSS sponsored in cooperation with the key Latin American agencies in late August, two global experts probed the challenges that moving a bioprocess from one location to another pose and what can be done to assure that the transfer goes smoothly. They shed a lot of light, for example, on what global comparability protocols could look like if ICH Q12 were to open the door to their use.
The first of the two stories focuses on the insights offered by Roche/Genentech’s Mary Cromwell on the drivers for a global company like Roche to make these site transfers and the key role that stress studies are playing in assuring comparability.
The second story shifts to the discussion by Biologic Consulting Group’s Christina Vessely of the analytical methods handoff – how it is pivotal to the overall success of the biomanufacturing transfer process, the different problems that can occur if that methods handoff is not done mindfully, and how firms can deal with the challenges involved.
Included are about two dozen “Updates in Brief” on breaking developments, which include links to all the documents referenced and to our related in-depth stories. Also in the issue is a full listing of the drug GMP warning letters and recalls posted by FDA during September.
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