Supplier Qualification General Chapter, sponsored by Xavier Health: Status Update

Through USP’s public standards setting process, we received a proposal from Xavier Health for a new USP-NF General Chapter with a tentative title “User Qualification of Upstream Supply Chain of Pharmaceutical Excipients”. The impetus for this proposal was the need for development of consistent, standardized, intentional and robust solutions for supply chain partner management and development.

USP posted a General Chapter Prospectus under Compendial Notices as part of the pilot process to solicit input during the early stages of chapter development. Input is considered Advisory Only and is therefore non-binding. The prospectus described a General Chapter numbered above 1000, and would therefore be for informational purposes only. The expected benefits for stakeholders across the supply chain were highlighted as:

Shifting resources from trying to improve supplier performance to improving internal performance that affects the ability of the suppliers to perform well.

  • Enabling industry to take ownership of the failure modes impacting supply chain integrity
  • Enabling industry to develop solutions that will reduce risk to product quality
  • Enabling global regulators to understand critical root causes to supply chain integrity and therefore product quality risk

Following input on the prospectus indicating the proposed General Chapter should not be limited to Excipients, and noting that the principles supplied in the Xavier process could be applied more widely, USP has modified the scope of the General Chapter, formed a Joint Subcommittee and gained support from multiple USP divisions responsible for all aspects of Supply Chain from raw materials through packaging.

The proposed General Chapter is now proceeding through USP’s public standards setting process, with participation drawn from industry and regulatory professionals, and opportunities for public comment through USP’s Pharmacopeial Forum. Check back to learn when the proposed chapter appears in PF. Target publication in USP-NF is expected in 18-24 months.

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