Lifecycle Approach to Analytic Methods for Drug Products: Design, Qualification, Continuing Verification

Gregory Martin

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Key Points:

  • Learn how to apply QbD concepts to Analytical Methods
  • Discover how a lifecycle approach can link method development, validation, verification and transfer
  • Learn how the Analytical Target Profile can drive the Lifecycle Approach
  • Learn about the importance of linking method uncertainty to specifications
  • Using a method feedback loop to facilitate method improvement


This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts.  By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises.  The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts of Risk Assessment and Control Strategy, and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically.  This approach will be linked with current compendial requirements.  There will be ample opportunity for questions and interaction throughout the course.


Learning Objectives:

  • Understand the lifecycle approach to method development and validation.
  • Identify an Analytical Target Profile for methods being developed
  • Use a Lifecycle Approach to method qualification
  • Develop appropriate protocols for method transfer
  • Comply with compendial requirements with greater success and fewer resources

Areas Covered

  • Introduction: Using a Lifecycle Approach for Pharmaceutical Analytical Procedures
  • Method Design: Introducing the concept of the Analytical Target Profile
    • What is an Analytical Target Profile?
    • ATP for Assay or uniformity, Dissolution or Stability indicating methods
    • Risk Assessment and development of a Control Strategy
  • Method Qualification
    • Rationale for demonstrating the validity of an analytical method
    • Life cycle approach to method validation
    • Applying the concepts of ICH Q2 and USP <1225>
    • Design of validation experiments
      • Establishing acceptance criteria
  • Continuing Verification of Analytical Methods
    • Method Modifications: Change control and method revalidation strategies
    • Verification of Compendial Procedures
    • Method Transfer
    • Troubleshooting analytical methods
  • Questions and discussion

Who Will Benefit:

Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

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Training CD-USB

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Recorded video

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Speaker: Gregory Martin,

Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance

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