Background During the commercial manufacturing phase of the product lifecycle, specific
elements of the PQS are used to identify and manage PACs. Per ICH Q10, these include …

Product knowledge grows and evolves during the life of a product. In order to maintain a
state of control and deliver product with consistent quality throughout its commercial life …

Even before the advent of biosimilar products, biopharmaceutical products faced life-cycle
concerns. The discovery–development–licensure process is just the beginning. Drug …

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 …

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 …

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 …

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 …

Deviations from approved standards in product or process conditions may occur at any
stage of production, processing, packaging, storage, transportation, or testing in the …

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 …

In recent months, FDA has begun championing Quality Management Maturity (QMM), a new
quality surveillance initiative intended to raise awareness at all levels of management in the …