Based on USP General Chapter <1220>, this course provides an understanding of how to apply the Analytical Procedure Life Cycle approach. Participants will examine the analytical procedure attributes and parameters, risks associated with procedure design, and strategies used to qualify procedures and to perform continuous performance verification.

Course activities include case studies to reinforce knowledge.

Subject area:
Drug Products & APIs

Objectives (If applicable):
• Define the Analytical Procedure Life Cycle, as per USP <1220>.
• Explain the importance of the Analytical Target Profile and its impact on a procedure.
• Understand the application and importance of AQbD within the APLC framework.
• Learn key aspects of the quality risk management process as applied to all stages of the APLC.
• Describe identification of critical procedure quality attributes, critical procedure parameters, and risk assessment.
• Explain how to establish Analytical Procedure Performance Characteristics criteria.
• Learn how to define Method Operable Design Region (MODR) and establish analytical control strategies for the procedure.
• Understand how software can be used to design experiments and confirm that an analytical procedure is suitable for its intended purpose.
• Conduct procedure qualification and ongoing procedure verification.

Target Audience (If applicable):
Compendial Liaison
QA manager
QA staff
QC chemist
QC manager
R&D
Regulator