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GOOD MANUFACTURING PRACTICE GUIDELINE FOR …
Ethiopian Food, Medicine & Healthcare Administration & Control Authority (EFMHACA) good MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS MAIN PRINCIPLES First Edition, 2014 Addis Ababa, Ethiopia i Table of Contents ACKNOWLEDGMENTS .. viii DEFINITIONS .. 2 CHAPTER ONE-QUALITY 11 Principle .. 11 Quality Assurance .. 11 good MANUFACTURING PRACTICE for Products .. 12 Quality Control .. 12 Product Quality Review .. 13 Quality Risk Management .. 14 CHAPTER TWO- SANITATION AND HYGIENE .. 15 Principle .. 15 General .. 15 CHAPTER THREE-PREMISES .. 16 Principle .. 16 Premises .. 16 General Requirement .. 16 Production Area .. 16 Storage Area .. 17 Quality Control Area .. 18 Ancillary Area .. 18 Principle .. 19 General Requirement .. 19 CHAPTER 20 Principles .. 20 General .. 20 Starting Materials .. 20 Packaging Materials .. 21 Intermediate and Bulk Products .. 21 Finished Products.
GOOD MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS MAIN PRINCIPLES First Edition, 2014 ... becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of ...
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