PT  - JOURNAL ARTICLE
AU  - Richard Rolke
AU  - Emma Ramnarine
AU  - Anders Vinther
AU  - Anil Sawant
TI  - Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
AID  - 10.5731/pdajpst.2019.011239
DP  - 2020 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 286--288
VI  - 74
IP  - 2
4099  - http://journal.pda.org/content/74/2/286.short
4100  - http://journal.pda.org/content/74/2/286.full
SO  - PDA J Pharm Sci Technol2020 Mar 01; 74
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.