Opening
Introductions
General Overview
Drug Development and Stability
Regulatory Guidelines Governing Stability Testing Operations
FDA Regulations
FDA Guidelines
Regulations and Guidelines for Europe
ICH Background
ICH Stability Guidelines Overview
Other ICH Guidelines Relevant to Stability
The difference between FDA and EU as it relates to ICH
ICH Guidelines for Stability: USA, EU, Japan, and Rest of World (ROW), A Detailed Look
Detailed Review of ICH Stability Guidelines
Q1A(R2) Stability Testing of New Drug Substances and Products
Q1B Photostability Testing of New Drug Substances and Products
Q1C Stability Testing for New Dosage Forms
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q1E Evaluation of Stability Data
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Product
What SOPs do you need?
What stability SOPs structure is important to your program
Stability Chambers
Kind of chambers
Options for your chamber
IQ and OQ of your chamber
Sample orientation for your chamber
Stability Protocols
What Should be Included in a Protocol
FDA assistance
EU assistance
Testing Considerations
Specifications
Impurities
Stability Indicting Test Methods
Parenterals
Validation
What is necessary for each stage
Design Stability Protocols for Commercial Drug Products
Establishing an Expiration Date
Commercial
Early Drug Development
Design Stability Protocol
Data Analysis
Linear Regression
Arrhenius plot
Reference Standard
Primary Standard
Compendial vs. non-compendial
USP and international vs. new chemical entity
Working standard
Out of specification (OOS) and Out of trend (OOT)
Stability Reports
What Should be Included in a Report
The Binder
Prepare, Execute, and Respond for a Regulatory Inspection
Pre approval inspection
Annual inspection
European inspection
State inspection
FDA’s authority for enforcement
Resources to prepare for the inspection
Executing the Inspection
Responding to the Inspection
483 Observations
Establishment Investigation Report
Warning Letter
18(hours)