Changes occur throughout a product's commercial life—changes in raw materials,
manufacturing equipment, processes, sites, analytical methods, and suppliers. A product …

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 …

Introduction: Product lifecycle management is a business strategy that pharmaceutical
manufacturers use to maintain revenue streams from their leading drug products. Post …

The functioning of pharmaceutical company does not stop when a drug product is approved
and its marketing starts. When a product is first approved, its manufacturing process …

The composite of the present pharmaceutical industry requires more effective medication
improvement and generation. A product lifecycle (PLC) is the progression of stages from the …

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 …

Pharmaceutical and biotechnology companies making products for human use have an
obligation to ensure that their products are safe, effective, meet established regulatory …

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 …

A product lifecycle is the succession of stages from the product's birth until its final
withdrawal from the market. While each stage brings significant changes, a succession of …

Written especially for the pharmaceutical industry professional, this book addresses each
part of the life-cycle of engineering change control. It covers issues in the EU and US and …