2021 - Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Introduction of a Stability Testing Plan and Program
Applicable Regulation and Requirements
General Stability Considerations Applicable to a New Product (i.e. Potency)
Storage Conditions
Shelf Life Duration of Studies and Expiration Dates
Container Closure Requirements
Sample Size
Sampling Plan
Handling and Analysis of Samples
Stability Schedule (Suggested Schedules for Conducting Stability Studies)
Pre-approval and Post Approval Studies
Stability Tests
Reformulated Products
Accelerated Temperature Studies
Test Schedule Information
Suggested Time Points and Expiration Dates Based on Testing Time Points
Solid Dosage Forms Suggested Test Schedule
Liquid and Semi-solid Types Products Suggested Test Schedule
Reconstituted Products Suggested Test Schedule
Temperatures of Studies Based on the Product Type
Room Temperature Studies
Elevated Temperature
Refrigeration
Freezing Temperature
Special Humidity Considerations
Analytical Testing Considerations
Quality Control Release Assays and Methods
Criticality of the Choice of Test that are Stability Indicators
Choice of Methods with Meaningful Data or Stability Indicator
Method Attributes
Method Attributes
Stability Testing Protocol Design
How to Design a Protocol and a Report
Stability Testing Data Management and Trending
Trending Data
Expiration Dating Extrapolation Using Data
Manual versus Automated Data Management
Advantages and Disadvantages