ASEAN Stability Study Guideline for Drug Product.pptx

Overview of ASEAN guidelines for drug product stability studies and requirements.

1. ASEAN Stability Study Guideline Overview of ASEAN guidelines for drug product stability studies and requirements.

2. List of Contents Introduction Objectives and Scope Design General and Storage Conditions Annexes Protocols and Statistical Approaches

3. Introduction Stability Essential for quality and efficacy Insufficient Stability Causes physical and chemical changes Objective Determine shelf-life ASEAN Condition Zone IVb (30°C/75% RH)

4. Objectives and Scope Recommendations Core stability study package Flexibility Specific scientific considerations Shelf-life Based on stability data Coverage NCE, Generics, and Variations

5. Design: General Knowledge Based Drug substance properties Photostability Primary batch testing ICH Q1B Appropriate guidelines

6. Design: Batch Selection 3 NCE Batches Minimum primary batches 2 Generic Batches Pilot scale batches 3 Critical Batches Primary batches required

7. Design: Specification Specification Tests and acceptance criteria Shelf-life Derived from stability data Differences Justifiable differences allowed

8. Design: Testing Parameters Attributes Susceptible to change Testing Physical and chemical Validation Analytical procedures