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ASEAN GUIDELINE ON STABILITY STUDY OF DRUG …

ASEAN GUIDELINE ON STABILITY STUDY OF drug PRODUCT Update revision : 22 February 2005. 9th ACCSQ-PPWG Meeting, Philippines, 21-24 Feb 2005 LIST OF CONTENTS Page 1. introduction 1 2. OBJECTIVES 1 3. SCOPES 1 4. DESIGN 1 General 1 Photostability Testing 2 Selection of Batches 2 Specification (Testing Parameter) 2 Testing Frequency 6 Storage Condition (General Case) 7 For NCE drug Products 9 For Generics and Variation (MaV and MiV if appropriate) Products 10 drug Products Intended for Storage in a Refrigerator 10 drug Products Intended for Storage in a Freezer 11 drug Products Intended for Storage Below -20 C 11 Container Closure System 11 Evaluation 12 STABILITY Commitment 14 Statements/Labeling 15 5.

INTRODUCTION 1 2. OBJECTIVES 1 3. SCOPES 1 4. DESIGN 1 4.1. General 1 4.2. ... Drug Products Intended for Storage in a Freezer 11 ... for a dose delivery system). The analytical procedure should be fully validated and stability indicating according to ASEAN guideline on Analytical Validation. Whether and

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