Lean Approaches to Development of HPLC Methods for Drug Products

Why Should You Attend:

This webinar is designed to offer an efficient, lifecycle approach to develop analytical methods for drug products. Starting by identifying the analytical target profile, several discrete steps will be explored which will lead to method validation designed to meet the needs of the developer.

Once the specificity requirements are understood, a technique that starts with gradient elution to understand the ‘chromatography space’ moves to focused conditions and explores ‘method understanding. It will effectively help prepare for method validation and subsequent method transfer. Attendees will also have the opportunity to be a part of a Q&A discussion with the presenter at the end of the session.

Upon completion of the course, attendees will be able to:

• Identify the various stages in the lifecycle of an analytical method and be aware of strategies to address the requirements for each stage.
• Apply the concept of analytical target profile for improving the design and evaluation of analytical methods.
• Gather the information necessary for successful method development, and use a ‘gradient-first’ approach to accelerate identification of suitable chromatographic conditions.
• Develop an understanding of analytical method performance to avoid common pitfalls.
• Prepare for successful method validation, demonstrating that the method is suitable for its intended use.

Areas Covered in the Webinar:

• Overview of a lifecycle approach to develop and validate analytical methods.
• Identifying the analytical target profile: what is the intended use of the method, and what desired characteristics (analytical technique, time constraints, solvent limitations, etc.) have been identified.
• Information gathering: what is known (or needs to be known) about the compound and the drug product?
• Using gradient elution HPLC to characterize the ‘chromatographic space’.
• Polishing the chromatography: pulling together the specificity requirements and the chromatographic characteristics.
• Developing understanding about the method and searching for weaknesses.
• Systematic evaluation of method parameters: robustness and intermediate precision.
• Preparing for validation and for method transfer.

Who Will Benefit:

• Chemists
• Managers responsible for development or validation of analytical methods
• Quality assurance personnel responsible for laboratory and analytical methods
• Regulatory affairs/CMC personnel responsible for filings involving analytical methods

Instructor Profile:

Gregory P. Martin is president of Complectors Consulting which provides consulting and training in the area of pharmaceutical analytical chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry and was director of pharmaceutical analytical chemistry (R&D) for a major pharma 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, residual solvents and use of enzymes for dissolution testing of gelatin capsules.

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. He is also past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.

Topic Background:

Starting by identifying the analytical target profile (e.g. the intended use for the method and whatever constraints exist), several discrete steps are explored which will lead to a validatable method designed to meet the needs of the developer. Once the specificity requirements are understood (using forced stress testing if appropriate), a technique that starts with gradient elution to understand the ‘chromatography space’, moves to focused conditions (using isocratic chromatography if appropriate) and explores ‘method understanding’ (including searching for weaknesses in the procedure) will effectively prepare for method validation and subsequent method transfer.

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