RT Journal Article
SR Electronic
T1 PDA Paper:
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2016.007492
DO 10.5731/pdajpst.2016.007492
A1 Emma Ramnarine
YR 2017
UL http://journal.pda.org/content/early/2017/01/14/pdajpst.2016.007492.abstract
AB 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.