RT Journal Article
SR Electronic
T1 One-Voice-of-Quality (1VQ) Industry Position Paper 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 pdajpst.2019.011239
DO 10.5731/pdajpst.2019.011239
A1 Richard Rolke
A1 Emma Ramnarine
A1 Anders Vinther
A1 Anil Sawant
YR 2020
UL http://journal.pda.org/content/early/2020/03/16/pdajpst.2019.011239.abstract
AB It is important to identify, assess and address current barriers to implementation of post approval changes that are intended to ensure continued (un-interrupted) operations, drive innovation and continual improvement in a maximally efficient, agile, flexible Pharmaceutical manufacturing sector. Leveraging ICH Q10 provides regulatory relief when it comes to addressing changes related to excipients, specifically excipient supplier′s name and address changes which will ensure and sustainable reliable global supply and availability of high quality product to patients through the entire commercial lifecycle of a product without extensive regulatory oversight.