This course will cover the main aspects USP General Chapter <1079> Supply Chain Risks and Mitigation Strategies on the Storage and Transport of Finished Drug Products and will include <1083> Supplier Qualifications. The content will consist of good practices approach, as well as risk and mitigation strategies for storage and transportation of a finished drug product. A quality risk-based approach will be discussed on how to select, assess, approve, and monitor suppliers of ingredients, packaging materials, and other components and services.

Subject area:
cGMP
Drug Products & APIs

Objectives (If applicable):
• Explain the concept and main risks of a supply chain.
• Describe the main mitigation strategies for
risks in storage and distribution.
• Build a quality management system based on risks and their mitigation strategies.
• Summarize approaches that can be used to keep materials or products within required labeled specifications.
• Describe the key points for temperature excursion handling and temperature mapping.
• Identify the main steps in the supplier qualification life cycle.
• Explain the audit process used for compliance with good distribution practices.
• Build an aid-memoire to conduct audits.

Target Audience (If applicable):
Analytical scientists
QA/QC analysts
Manufacturing scientists, managers
Regulatory affairs specialists
Contract manufaturing organizations
Regulators
Distributors
Freight Forwarders