Module 3 - Strategic case studies in practice

23 August 2017 Q11 Q&As

Table of Contents

PREFACE ........................................................................................... 4 1. INTRODUCTION ......................................................................... 5 2. SCOPE ....................................................................................... 5 3. MANUFACTURING PROCESS DEVELOPMENT ................................ 5 4.

DESCRIPTION OF THE MANUFACTURING PROCESS AND PROCESS CONTROLS ................................................................................ 5 5. SELECTION OF STARTING MATERIALS AND SOURCE MATERIALS . 6 6. CONTROL STRATEGY ............................................................... 16 7. PROCESS VALIDATION/EVALUATION ........................................ 16 8. SUBMISSION OF MANUFACTURING PROCESS DEVEOPMENT AND RELATED INFORMATION IN THE COMMON TECHNCICAL DOCUMENT (CTD) FORMAT .................................. 17 9. LIFECYCLE MANAGEMENT ....................................................... 17 10. ILLUSTRATIVE EXAMPLES ....................................................... 17 11. GLOSSARY ............................................................................... 17 12. ANNEX 1: DECISION TREE ........................................................ 17

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