- Author(s):
- Organization(s):
AstraZeneca Faegre Drinker Consulting GSK International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) Merck
There is concern by all industry stakeholders about what it will take to establish clinically relevant limits based on test results obtained from analytical methods proven to have a predictive in vitro/in vivo (IVIV) relationship; as well as how to establish product quality limits, in the absence of an IVIV correlation, that have some quantitative relationship with the characteristics associated with acceptable and/or unacceptable clinical performance. This opinion article proposes a better way to set specifications and control quality.
The approach would: demonstrate strong commitment to quality, efficacy and safety, as integrated components of good business practices; align quality standards and statistical methods for assessing adherence to those standards to maximize patient benefit with respect to safety and efficacy as well as maximizing availability of good product; result in, potentially, faster regulatory approvals because clearer processes and sampling plans should make it easier to demonstrate compliance with regulatory standards; and enable a clearer understanding of how changes in a manufacturing or analytical process directly relate to critical quality attributes, allowing the sponsor company to better evaluate risk of any deviation and—importantly for preventing drug shortages—quickly and comprehensively respond to changes in the supply chain.
October 2024, Volume 18(5), pages 22-29