The US Pharmacopeia is proposing a new informational chapter on Supplier Qualification – <1083>. This was previously published as a chapter on good distribution practices and now <1083> is repurposed to focus on a risk-based approach to Supplier Qualifications.
The initiative has its roots in a white paper “Good Supply Practices for the 21st Century”, published by Xavier Health in 2018 and will discuss the importance of supplier qualification and the application of a quality risk-based approach.
The chapter outlines examples of supplier types that should be qualified, a six-step process of Supplier Qualification Life Cycle Management along with points to be considered in a risk assessment broken down by risk category.
While the USP general chapters numbered <999> and above are general guidelines rather than being enforceable by law, <1083> contains some good indications on the use of risk-based supplier qualifications. Commenting on <1083> is open until 30 November 2021.
NOTE: To access the document requires an account with USP- which can be created for free on the USP website.