Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System

PDA J Pharm Sci Technol. 2020 Mar-Apr;74(2):286-288. doi: 10.5731/pdajpst.2019.011239. Epub 2020 Mar 16.


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.

Keywords: Chemistry, Manufacturing and Controls (CMC); Excipient supplier name changes; International Conference for Harmonisation (ICH) Q10; Pharmaceutical quality system (PQS); Post-approval change (PAC); Quality risk management; Regulatory; Regulatory relief; Risk Implementation.

Publication types

  • Review

MeSH terms

  • Chemistry, Pharmaceutical / methods
  • Chemistry, Pharmaceutical / standards*
  • Drug Industry / methods
  • Drug Industry / standards*
  • Equipment and Supplies Utilization / standards*
  • Excipients / standards*
  • Humans
  • Quality Control*


  • Excipients