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GOOD MANUFACTURING PRACTICE GUIDELINE …

Ethiopian Food, Medicine & Healthcare Administration & Control Authority (EFMHACA). good MANUFACTURING PRACTICE GUIDELINE . FOR pharmaceutical PRODUCTS. MAIN PRINCIPLES. First Edition, 2014. Addis Ababa, Ethiopia Table of Contents ACKNOWLEDGMENTS .. viii DEFINITIONS .. 2. CHAPTER ONE-QUALITY 11. Principle .. 11. Quality Assurance .. 11. good MANUFACTURING PRACTICE for 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.

Ethiopian Food, Medicine & Healthcare Administration & Control Authority (EFMHACA) GOOD MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS

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