ASEAN GUIDELINE

ON STABILITY STUDY OF DRUG PRODUCT

(R1)

Revision

25th ACCSQ-PPWG
LIST OF CONTENTS
Page
1. INTRODUCTION 1
2. OBJECTIVES 1
3. SCOPE 1
4. DESIGN 1
4.1. General 1
4.2. Photostability Testing 1
4.3. Selection of Batches 1
4.4. Specification 2
4.5. Testing Parameters 2
4.6. Testing Frequency 6
4.7. Storage Conditions 6
4.7.1. General Case 6
4.7.2. Drug Products Packaged in Impermeable Containers 7
4.7.3. Drug Products Packaged in Semi-Permeable Containers
(Aqueous-Based Products) 8
4.7.4. Drug Products Intended for Storage in a Refrigerator 9
4.7.5. Drug Products Intended for Storage in a Freezer 9
4.7.6. Drug Products Intended for Storage Below -20ºC 9
4.7.7. NCE Drug Products 9
4.7.8. Generic Products 10
4.7.9. Variations (MaV and MiV if appropriate) 10
4.8. In-use Stability 11
4.9. Container Closure System 12
4.10. Evaluation 12
4.10.1. Data Presentation 13
4.10.2. Extrapolation of Data 13
4.10.3. Data Evaluation for Shelf-Life Estimation for Drug Products Intended for
Storage at Room Temperature 14
4.10.4. Data Evaluation for Shelf-Life Estimation for Drug Products Intended for
Storage below Room Temperature 16
4.10.5. General Statistical Approaches 17
4.11. Stability Commitment 18
4.12. Statements/Labeling 19
5. ANNEXES 20
5.1. Protocol of Stability Study (example) 20
5.2. Report Format (example) 24
5.3. Reduced Design (Bracketing and Matrixing) 30
5.4. Examples of Types, Thickness and Permeability Coefficient of Packaging 32
Materials
5.5. Decision Tree for Data Evaluation for Shelf-Life Estimation for Drug Products 34
(excluding Frozen Products)
5.6. Examples of Statistical Approaches to Stability Data Analysis 35
6. GLOSSARY 36
7. REFERENCES 40