Lifecycle Approach to Pharmaceutical Analytical Methods
Learn about a systematic approach to the development of analytical methods designed to improve the performance of those methods during application across their lifecycle. Identifying critical method performance characteristics and developing understanding of the impact of method parameters allows demonstration that a method is capable of meeting the requirements necessary for optimal performance. This course will use real life case studies to show how this approach results in consistent quality performance during routine application, with fewer method-related Out of Specification results and improved method transfer.
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.
1. Introduction: Using a Lifecycle Approach for Analytical Procedures
2. Method Design: Introducing the concept of the Analytical Target Profile
– Practical Exercise: Developing an ATP
3. Method Development Using the ATP as a Tool
– Assay or uniformity
– Stability indicating methods
– Practical Exercise: Approach to developing a stability indicating method
4. Method Validation: Applying the concepts of ICH Q2 and USP <1225>
– Rationale for demonstrating the validity of an analytical method
– Life cycle approach to method validation
– Design of validation experiments
– Practical Exercise: Designing a validation protocol
5. Method Modifications: Change Control and Method Revalidation Strategies
6. Verification of Compendial Procedures
7. Method Transfer
8. Troubleshooting Analytical Methods
9. Questions and Discussion
Mr. Greg 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 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, 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.