E23-06: Analytical Method Validation and Lifecyle Management – FDA, ICH and USP Expectations

One-Day Course
Sunday, November 12; 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 to distinguish qualification expectations of validation, verification, and transfer through product lifecycle. This course will review the current regulations from FDA, ICH, and USP, and various aspects of validation throughout development phases of drug development.  This is also critical to build a solid foundation to support analytical lifecycle development by establishing the analytical target profile and critical analytical attributes. It will also discuss change strategies to analytical procedures. Participants are expected to share their experiences and discuss relevant lab practices to keep the method in 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 and the discussion focuses primarily on separation sciences.

1.  Regulatory Expectations of Method Validation.
a. Current review of critical GMP issues in analytical labs.
b. Review ICH Q2R1 guidelines and FDA Guidance for Industry.
c. USP <1225>, <1226> and <1224> requirements.
d. Working with USP Monographs and General Chapter <1220>.
2. Establish Analytical Target Profile to Support Lifecycle Management.
a. Discuss validation characteristics and purpose of stress testing.
b. Verification of compendial methods.
b. Key strategies of Method Transfer.
c. Differentiate validation, verification, and transfer.
3. Lifecycle and Change Management of Analytical Procedures.
a. Types of changes to analytical Method.
b. Structure validation protocol and establish acceptance criteria.
c. Discuss validation by phases to support analytical lifecycle.

Kim Huynh-Ba is the Managing Director of Pharmalytik Consulting (www.pharmalytik.com), 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 Chemical Medicines Monographs 4 Expert Committee for the 2020-2025 cycle. Kim is part of the Governing Board of EAS. 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 50 technical publications and book chapters.  She edited 3 book volumes and recently published “Analytical Testing for the GMP Pharmaceutical Laboratory”.