PT  - JOURNAL ARTICLE
AU  - Richard Rolke
AU  - Emma Ramnarine
AU  - Anders Vinther
AU  - Anil Sawant
TI  - One-Voice-of-Quality (1VQ) Industry Position Paper Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
AID  - 10.5731/pdajpst.2019.011239
DP  - 2020 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2019.011239
4099  - http://journal.pda.org/content/early/2020/03/16/pdajpst.2019.011239.short
4100  - http://journal.pda.org/content/early/2020/03/16/pdajpst.2019.011239.full
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.