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

Table of Contents

ACKNOWLEDGMENTS ...............................................................................................................viii DEFINITIONS.................................................................................................................................. 2 CHAPTER ONE-QUALITY MANAGEMENT............................................................................... 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 FIVE-MATERIALS...................................................................................................... 20 Principles .................................................................................................................................... 20 General........................................................................................................................................ 20 Starting Materials ........................................................................................................................ 20 Packaging Materials .................................................................................................................... 21 Intermediate and Bulk Products ................................................................................................... 21 Finished Products ........................................................................................................................ 22 Rejected, Recovered, Reprocessed and Reworked Materials ........................................................ 22 Recalled Products ........................................................................................................................ 22 Returned Products ....................................................................................................................... 22

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Reagents and Culture Media ........................................................................................................ 22 Reference Standards .................................................................................................................... 23 Waste Materials........................................................................................................................... 23 Miscellaneous.............................................................................................................................. 23 CHAPTER SIX-PERSONNEL........................................................................................................ 24 Principle...................................................................................................................................... 24 General........................................................................................................................................ 24 Key Personnel ............................................................................................................................. 24 Training....................................................................................................................................... 26 Personnel Hygiene....................................................................................................................... 26 CHAPTER SEVEN-PRODUCTION ............................................................................................... 28 Principle...................................................................................................................................... 28 General........................................................................................................................................ 28 Prevention of Cross Contamination in Production ........................................................................ 29 Validation.................................................................................................................................... 29 Starting Materials ........................................................................................................................ 30 Processing Operation-Intermediate and Bulk................................................................................ 30 Packaging Operations .................................................................................................................. 30 CHAPTER EIGHT-QUALITY CONTROL..................................................................................... 32 Principle...................................................................................................................................... 32 General........................................................................................................................................ 32 Good Quality Control Laboratory Practice ................................................................................... 32 Documentation ............................................................................................................................ 32 Sampling ..................................................................................................................................... 33 Testing ........................................................................................................................................ 33 Stability Study Monitoring........................................................................................................... 34 CHAPTER NINE-CONTRACT PRODUCTION AND ANALYSIS................................................ 37 Principle...................................................................................................................................... 37 General........................................................................................................................................ 37 The contract giver........................................................................................................................ 37 The Contract acceptor.................................................................................................................. 37 The Contract................................................................................................................................ 38 CHAPTER TEN-COMPLAINTS AND PRODUCT RECALL ........................................................ 39 Principle...................................................................................................................................... 39

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Complaints .................................................................................................................................. 39 Recall .......................................................................................................................................... 39 CHAPTER ELEVEN- SELF INSPECTION AND QUALITY AUDITS .......................................... 41 Principle...................................................................................................................................... 41 General........................................................................................................................................ 41 CHAPTER TWELVE- VALIDATION AND QUALIFCATION ..................................................... 42 Principles .................................................................................................................................... 42 Validation.................................................................................................................................... 42

Qualification............................................................................................................................ 42 Design Qualification ................................................................................................................ 42 Installation Qualification.......................................................................................................... 43 Operational Qualification......................................................................................................... 43 Performance Qualification ....................................................................................................... 43 Process Validation ....................................................................................................................... 43 General.................................................................................................................................... 43 Prospective Validation ............................................................................................................. 44 Concurrent Validation.............................................................................................................. 44 Retrospective Validation.......................................................................................................... 45 Qualification of Established (in use) Facilities, Systems and Equipment....................................... 45 Cleaning Validation..................................................................................................................... 45 Change Control ........................................................................................................................... 46 Computerized System .................................................................................................................. 46 Principle .................................................................................................................................. 46 General.................................................................................................................................... 46 System..................................................................................................................................... 47 Validation................................................................................................................................ 48 Hardware Validation................................................................................................................ 49 Analytical Method Validation Principle ....................................................................................... 50 General.................................................................................................................................... 50 Pharmacopoeial method........................................................................................................... 51 Non-pharmacopoeial method ................................................................................................... 51 Method Validation ................................................................................................................... 51 Characteristics of analytical validation ..................................................................................... 51 System Suitability Testing ....................................................................................................... 53

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Revalidation ................................................................................................................................ 53 CHAPTER THIRTEEN-DOCUMENTATION................................................................................ 54

Principle...................................................................................................................................... 54 General........................................................................................................................................ 54 Essential Documents Specifications ............................................................................................. 55

Specifications for starting and packaging materials .................................................................. 55 Specifications for intermediate and bulk products .................................................................... 55 Specifications for Finished Products ........................................................................................ 55 Batch Formula and Processing Instruction................................................................................ 55 Packaging Instructions ............................................................................................................. 56 Batch Processing Records ........................................................................................................ 56 Batch Packaging Records......................................................................................................... 57 Procedures and Records ........................................................................................................... 58 CHAPTER FOURTEEN-WATER FOR PHARMACEUTICAL USE.............................................. 60 Principle...................................................................................................................................... 60 General........................................................................................................................................ 60 Water Quality Specification ..................................................................................................... 60 Drinking Water........................................................................................................................ 61 Purified Water ......................................................................................................................... 61 Highly Purified Water.............................................................................................................. 61 Other Grades of Water ............................................................................................................. 61 Application of Specific Water for Dosage Form Processing ......................................................... 62 Water Purification ....................................................................................................................... 62 General.................................................................................................................................... 62 Production of Drinking Water .................................................................................................. 63 Production of Purified water .................................................................................................... 63 Production of Highly Purified Water ........................................................................................ 64 Water Storage and Distribution .................................................................................................... 64 General.................................................................................................................................... 64 Sanitization of Water System ................................................................................................... 66 Storage Vessel ......................................................................................................................... 66 Water Distribution Pipe ........................................................................................................... 67 Temperature Control and Heat Exchangers .............................................................................. 67 Circulation Pumps ................................................................................................................... 67

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