USP with new Chapter on Supplier Qualification and Guidance for associated Risk Assessments
![Self Inspection - Live Online Training](files/eca/userImages/training.img/Z-ECA-Self-Inspection.jpg)
Recommendation
Thursday, 12 September 2024 13.00 - 16.45 h
Compliant and Successful Self-Inspections and Internal Audits
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 |
Related GMP News
26.06.202410 points on how the FDA's CDER monitors the Quality of Medicinal Products
08.05.2024EMA Plans for the next three Years
30.04.2024Lean GMP: is "right-sizing" GMP and Compliance possible?
24.04.2024Unexpected Deviations: the Role of the QP
10.04.2024FDA's current Thinking on KPIs and Quality Metrics
21.02.2024What is the African Medicines Agency?