Managing Director Globalworx GmbH Sasbach, Germany
Presentation will discuss USP's development of a supplier qualification guidance chapter which introduces a quality risk-based approach on how to select, assess, approve, and monitor suppliers of ingredients, materials, components, and services.
Introduction to the new USP Informational Chapter on Supplier Qualification in development
Draft chapter applies to suppliers for pharmaceutical, medical device, and dietary supplement manufacturing companies and compounding pharmacies
Draft chapter applies to organizations and individuals involved in identifying, selecting, assessing, approving and monitoring suppliers of materials
Recognize the need of standardization and the use of scientifically sound public standards that focus on the high-level elements of supplier qualification and that apply to all organizations.