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ASEAN GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA FOR DRUG REGISTRATION TABLE OF CONTENTS INTRODUCTION. 1. 1 Design and development 4. 1. 2 Establishing a Strategy for Process Control Stage 2 Process Qualification Stage 3 Continued Process Verification REGULATORY SUBMISSION OF DOCUMENTS IN ASEAN COMMON TECHNICAL FORMAT ACTD data for process validation which adopts quality by design QbD approach. ICH Quality Risk Management Q9 ICH Nov 2005 ICH Pharmaceutical Quality...
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