부산대학교 도서관

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 represents the current technology standard for manufacturing and follows the cGMP standard for regulatory compliance. After approval, market demand, technological advances, GMP standards, raw material sourcing or manufacturing experience may require that the approved process or product needs to be modified. Therefore, Post Approval Change management plays an important role in maintaining the marketing status of a drug product. For the purpose of carefully assessing and successfully implementing the changes in a pharmaceutical company, the company should have an efficient and well-defined change control system in place. Complying post approval requirements enables FDA and the pharmaceutical industry to make sure that the drug product is consistent in its quality, efficacy and safety throughout its lifecycle. [ABSTRACT FROM AUTHOR]