FDA Guidance on Analytical Procedures and Method Validation and its Relationship to ICH Q2 and USP <1220> Initiatives

The FDA issued the final guidance on “Analytical Procedures and Methods Validation for Drugs and Biologics,” in 2015. This guidance replaces the 2000 draft guidance on “Analytical Procedures and Method Validation” and a similar guidance issued in 1987. Over this span of time, the FDA has modified its approach to method validation from quite prescriptive to a reliance on risk management and a deep understanding of the purpose, science and statistics of control behind each of the characterization tests. The approach FDA takes in their guidance foreshadows and dovetails with ICH initiatives Q2(R2) and Q14 (Analytical Procedure Development and Revision of Q2(R1) Analytical Validation) and the United States Pharmacopeia General Chapter <1220> - The Analytical Procedure Lifecycle.

In this presentation we will review the current guidance in the context of FDA, USP and ICH current approaches to the whole topic of validation and concepts as the Analytical Target Profile, systematic method development and method and product lifecycle management. We will probe how this might impact the thinking behind the selection of methods and acceptance criteria for material characterization and the presentation of this information in regulatory filings. We will also discuss some of the key validation criteria and factors to consider when developing and validating methods that have been deleted from the guidance yet included by reference.

Learning Benefits

• Review the current FDA guidance on Analytical Procedures and Method Validation.
• An in-depth discussion of the guidance in light of FDA’s approach to method development and validation.
• A discussion of a science-based approach to the selection of methodology of material characterization and subsequent method validation, including updates to ICH Q2(R2) and ICH Q14 initiatives.
• New expectations related to the verification of compendial methodology.
• Method development and validation in the context of life-cycle management, including USP General Chapter <1220>.
• Critical quality attributes and critical process parameters as they relate to method selection, validation and control.

Who Should Attend

The following individuals or disciplines will benefit from attending this webinar:

• Quality Assurance Personnel
• Quality Control Personnel
• Regulatory Compliance Managers
• Analytical Chemists
• Laboratory Management
• Chemical Manufacturing and Control (CMC) Personnel