It is important to identify, assess, and address current barriers to implementation of post-
approval changes that are intended to ensure continued (uninterrupted) operations and …

Post-approval changes are inevitable and necessary throughout the life of a drug product—
to implement new knowledge, maintain a state of control, and drive continual improvement …

Failures surrounding pharmaceutical quality, particularly with respect to product
manufacturing issues and facility remediation, account for the majority of drug shortages and …

Post-approval changes are inevitable and necessary throughout the life of a drug product—
to implement new knowledge, maintain a state of control, and drive continual improvement …

While the pharmaceutical industry is globalized, regulations are regionalized. This means a
Marketing Authorization Holder (MAH) can manufacture a product at any of its cGMP global …

To meet the challenge of ensuring quality medicines to the American public and proactively
prevent drug shortage situations, the Center for Drug Evaluation and Research has formed …

Issues in product quality have produced recalls and caused drug shortages in United States
(US) in the past few years. These quality issues were often due to outdated manufacturing …

The submission and review of manufacturing supplements is costly and time consuming for
biopharmaceutical companies and for regulatory authorities in all regions, and a concerted …

Post-approval changes (PACs) are inevitable and necessary throughout the life of a drug
product. Because many PACs require prior approval by individual regulatory agencies each …

Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the
pharmaceutical quality environment. Globalization of the pharmaceutical industry …