E24-16: Analytical Method Validation and Lifecyle Management – FDA, ICH and USP Expectations

One-Day Course
Monday, Nov. 18; 8:30am – 5:00pm
Ms. Kim Huynh-Ba, Pharmalytik Consulting, Newark, DE


Analytical laboratories play key roles in the pharmaceutical industry. The generation of data that ensure its reliability and allow for post-analysis verification of its authenticity is critical to the drug development process; thus, keeping the analytical method in compliance with FDA, ICH and USP regulations is a challenge for analytical scientists. This course will review the current regulations using lifecycle approach to analytical procedures of pharmaceutical products, such as FDA validation guidance, ICH Q2(R2) revision, ICH Q14 concepts, and USP <1220>. Different aspects of validation throughout development phases to establish critical acceptance criteria will also be discussed to establish change control strategies for analytical procedures and application of quality risk management to support continual improvement. Participants are encouraged to discuss their practices on validation of analytical procedures and challenges to maintain compliance

Analytical chemists, GMP staff scientists, supervisors, directors, investigators in QC lab, R&D, production, manufacturing, contract labs, quality assurance, regulatory affairs, laboratory auditors, lab inspectors, data reviewers, lab investigators. This course is not intended for microbiologists.


  1. Regulatory Expectations of Method Validation
    • General Considerations for Analytical Procedures
    • Evaluate ICH Q2(R1) Guidelines and FDA Guidance for Industry
    • Understand USP General Chapters <1225>, <1226> and <1224> Relationship.
    • Working with USP Monographs and Structure
  2. Discuss the Framework of USP General Chapter <1220> Lifecycle Approach
    • Understand Key Concepts of Method Lifecycle and Prior Knowledge Supporting Validation.
    • Establish of Analytical Target Profile based on Quality-by-Design (QbD)
    • Discuss the Importance of Scientific Approaches to Method Development.
    • Discuss Quality Risk Management in Establishment of Method Control Strategies.
    • How Validation Activities Take Place Across the Entire Lifecycle of Analytical Procedure
  3. Analytical Procedures Lifecycle Approach ICH Q14 and Change Management
    • Understand Methods as Part of the Product Specifications.
    • Discuss ICH Q14 Concepts and Establish Conditions of Method Changes
    • Understand Minimal and Enhance Approaches of Method Validation
    • Structure Validation Protocol and Establish Acceptance Criteria.
    • Monitor Method Performance for Continual Improvement.

Kim Huynh-Ba is the Managing Director of Pharmalytik (www.pharmalytik.com) providing consulting and training, specializing in quality systems, validation, CMC and stability sciences. She is a member of the US Pharmacopeia’s Council of Experts and the Chair of the Small Molecules Monographs 4 Expert Committee for the 2015-2025 cycle. She was a member of USP Organic Impurities Expert Panels. Kim is a member of the EAS Governing Board and their 2013 President. She is an adjunct professor at Temple University‐ RAQA Program and Illinois Institute of Technology teaching Pharmaceutical Analysis, Quality audit, ICH Quality Guidelines, and GMP. Kim authored over 80 technical publications and book chapters. She is the editor of the “Stability Handbook in Pharmaceutical Laboratories” and more recently the textbook of “Pharmaceutical Testing for the Pharmaceutical GMP Lab”.