TY - JOUR T1 - PDA Paper: JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2016.007492 SP - pdajpst.2016.007492 AU - Emma Ramnarine Y1 - 2017/01/01 UR - http://journal.pda.org/content/early/2017/01/14/pdajpst.2016.007492.abstract N2 - Changes occur throughout a product's commercial life - changes in raw materials, manufacturing equipment, processes, sites, analytical methods, and suppliers. A product Marketing Authorization Holder (MAH) can introduce manufacturing changes as part of continual improvement to enable implementation of innovative technologies, exchange obsolete equipment, or improve the availability of drug products for patients. Changes are also made to comply with evolving regulatory requirements. Changes are a common and unavoidable part of a product's lifecycle. This Points to Consider paper is intended to focus on a company's technical product lifecycle management strategy. It includes elements and benefits of such a strategy, its use in post-approval change (PAC) management, and considerations to enable effective communication and knowledge sharing between MAHs and health authorities. ER -