Type of Posting: General Chapter Prospectus
Posting Date: 26–Mar–2021
Input Deadline: 25–Apr–2021
Expert Committee: General Chapters—Packaging and Distribution Joint Subcommittee*
Proposed New Title: <1XXX> Supplier Qualification
Suggested audience: Organizations and individuals involved in sourcing materials and services and in providing materials and services.
Estimated proposal PF: Pharmacopeial Forum 47(5) [Sep–Oct. 2021]
Background and objective(s): The manufacturers of pharmaceuticals and medical devices primarily source their required ingredients, materials, components, and services through external, local, and global suppliers. External suppliers also provide services such as research and development, manufacturing, assembly, analysis, packaging, warehousing, transportation, distribution, etc. This means that active ingredients, excipients, components, other raw materials, and packaging components used in the end-product are manufactured to the appropriate standards. It also means that the processes in the supply chain for a material or service are compliant with applicable regulations and requirements and do not increase risks to the product.
Reliable suppliers provide benefits through established risk management processes. Supplier Qualification is a process to systematically evaluate suppliers based on (i) the risk to the quality of the product or service supplied; (ii) compliance of their quality systems to applicable regulations and requirements of the Supply Contract or Quality Agreement; and (iii) the reliability of the supplier to avoid quality deviations and shortages of components and/or products.
Description of scope and application: This informational general chapter will provide a quality risk-based approach for organizations and individuals involved in identifying, selecting, assessing, approving, and monitoring suppliers of materials (e.g., active pharmaceutical ingredient, excipients, components, other raw materials), packaging material (e.g., primary, secondary, ancillary and shipping packaging), and service providers (e.g., contract manufacturing/packaging/repackaging, logistic providers for warehousing and transportation, software providers, calibration/qualification services, and analytical services).
The chapter will discuss supplier qualification within the context of its lifecycle, where the 5-step lifecycle process: Preparation, Identification and Selection, Evaluation and Acceptance, Performance Monitoring, and Disqualification will be elaborated.
In the development of this chapter, USP will leverage Xavier Health’s document titled Good Supply Practices for the 21st Century.
Anticipated proposed design phase activities:
AAPS PharmSci Webinar: USP Supplier Qualification, November 2020
45th Annual International Good Manufacturing Practices Conference 2021: Supplier Qualification March 2021
Contact: Desmond Hunt, Principal Scientific Liaison, Ph.D., (301-816-8341, email@example.com)
*The Joint Subcommittee is composed of members from the General Chapter (GC) Physical Analysis, GC Packaging and Distribution, Biologics Monographs 2 – Proteins, Small Molecules 4, Simple Excipients, Excipients Test Methods Expert Committees. The Joint Subcommittee will make recommendations to theGC Packaging and Distribution Expert Committee who will be responsible for the standard.