This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements.
It will also focus on how to interpret the data generated by the stability programs.
Why Should You Attend:
Performing stability studies is often considered a routine task in the development cycle. However, if they are not designed and executed properly the results can be disastrous.
Ineffective stability programs can lead to an assignment of shortened shelf life and/or delays in regulatory approvals. Given the options outlined in the ICH stability guidance, it is important to understand which options apply and how to implement them for your product.
This presentation will cover the ICH stability requirements, how to design the programs taking into account the drug product specifics and common challenges which can occur during these programs.
Learning Objectives:
- Understanding what are the requirements for ICH stability studies
- Learning the how to design stability programs for your drug product
- Understanding the analytical methods requirements
- How to interpret the data generated by the stability programs
Areas Covered:
- Background and Overview of ICH Q1
- What are the requirements for stability programs
- What are the analytical method requirements, what needs to be measured
- Stability indicating methods – what are they?
- Designing Stability Studies
- Standard programs vs matrixing vs. bracketing
- ANDA stability requirements
- Data Analysis
- Tracking and trending
- OOS vs OOT
- Setting specifications and shelf life
Instructor Profile
Dr. Wayland Rushing is a technical expert in chemistry, manufacturing and controls (CMC) program design, analytical development and regulatory submissions.
Over his 15-year career, he has led CMC development programs for a wide array of biopharmaceuticals, including parenterals, inhalation drugs, and other pharmaceuticals with complex delivery systems.
Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions; and assists ABC clients in responding to FDA deficiency letters.
He currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Presentation Summary and was co-author of PDA TR 65, Technology Transfer.