RT Journal Article SR Electronic T1 Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 286 OP 288 DO 10.5731/pdajpst.2019.011239 VO 74 IS 2 A1 Richard Rolke A1 Emma Ramnarine A1 Anders Vinther A1 Anil Sawant YR 2020 UL http://journal.pda.org/content/74/2/286.abstract AB It is important to identify, assess, and address current barriers to implementation of post-approval changes that are intended to ensure continued (uninterrupted) operations and drive innovation and continual improvement in a maximally efficient, agile, and flexible pharmaceutical manufacturing sector. Leveraging the International Conference for Harmonisation Quality Guideline Q10 provides regulatory relief when it comes to addressing changes related to excipients, specifically excipient supplier's name and address changes, which will ensure a sustainable, reliable global supply and the availability of high quality product to patients through the entire commercial lifecycle of a product without extensive regulatory oversight.