Strategies of Bringing Drug Product Marketing Applications to Meet Current Regulatory Standards
Journal Title: AAPS PharmSciTech - Year 2015, Vol 16, Issue 4
Abstract
In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.
Authors and Affiliations
Yan Wu, Anita Freed, David Lavrich, Ramesh Raghavachari, Kim Huynh-Ba, Ketan Shah, Mark Alasandro
Keywords
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