USP with new Chapter on Supplier Qualification and Guidance for associated Risk Assessments

As indicated earlier this year, the U.S. Pharmacopeia USP intends to publish a new informational chapter on Supplier Qualification. It was proposed by the General Chapters-Packaging and Distribution Expert Committee. The chapter will get the number <1083>, the former number of the proposed chapter on Good Distribution Practice GDP, which was dismissed.

The aim is to "discuss the importance of supplier qualification and the application of a quality risk-based approach to select, assess, approve, and monitor suppliers of materials and services". Core of the proposal is a six-step process:

  • Preparation
  • Identification and selection
  • Evaluation and acceptance
  • Performance monitoring
  • Disqualification
  • Conditional approval of an existing supplier

For each of these steps, expectations and the rationale of tasks are provided. It is also pointed out that quality risk-based approaches should be used and implemented throughout the process steps. A separate table lists examples of various items that can be considered as part of such a risk assessment. Even though the USP has no direct force of law, certainly not in Europe, interesting pointers for use in risk-based supplier qualification programmes can be found here.

The draft can be viewed in the Pharmacopeial Forum. (Please note: a one-time registration is required to access the Pharmacopeial Forum.)

Live Online Training:
Efficient Supplier Qualification
30/31 March 2022

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