USP: New General Chapter Supplier Qualification <1083>

Global Registration and Life Cycle Management for APIs

Recommendation

8-10 April 2025
Vienna, Austria

Global Registration and Life Cycle Management for APIs
Contents of the regulatory information in the ASMF and CEP

The new USP Chapter "<1083> Supplier Qualification" will officially come into force on 01 August 2023. As we previously reported, the draft chapter could be viewed and commented on in the USP Forum until the end of November 2021.

The final version of the new chapter now focuses on the three types of suppliers for:

Materials (e.g., active pharmaceutical ingredients, excipients, and other components and materials)
Packaging materials (e.g. primary, secondary and tertiary packaging)
Service providers (e.g., contract manufacturers, packers, or repackers; transportation and storage services; calibration and qualification services; analytical services; and software services).

The chapter, now final, is divided into the following paragraphs and subsections:

Introduction
Scope
Supplier Qualification Life Cycle: Steps for a Supplier Qualification
o Preparation
o Identification and Selection of Supplier for Materials and Services
o Evaluation and Acceptance
o Performance Monitoring
o Supplier Disqualification
o Conditional Approval of an Existing Supplier

Finally, it contains a "Glossary" which defines the terms most relevant to this chapter.

Further information can be found on the USP website.