SFDA GMP Guide Na

1 Version Date of publication 26 April 2011 Date of implementation 26 July 2011 2 Guide to Good Manufacturing Practice for Medicinal Products Version Saudi Food & Drug Authority Drug Sector For Inquiries For Comments Please visit SFDA s website at for the latest update 3 Saudi Food & Drug Authority Vision and Mission Vision To be a leading international science-based regulator to protect and promote public health Mission Protecting the community through regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides and feed 4 Document Control Version Author Date Comments Drug Sector June/2005 Draft Inspection and Law Enforcement Directorate 20 April 2011 Draft Inspection and Law Enforcement Directorate 26 July 2011 Final Inspection and Law Enforcement Directorate 08 August 2018 Update Operations Sector 5 April 2021 Update Table of contents 5 TABLE OF CONTENT Chapter 1 Pharmaceutical Quality System.

2 15 Principle .. 15 Pharmaceutical Quality System .. 15 Good Manufacturing Practice For Medicinal Products .. 18 Quality Control .. 19 Product Quality Review .. 20 Quality Risk Management .. 22 Chapter 2 Personnel .. 23 Principle .. 23 General .. 23 Key Personnel .. 24 Training .. 26 Personnel Hygiene .. 27 Consultants .. 28 Chapter 3 Premises And Equipment .. 29 Principle .. 29 Premises .. 29 General .. 29 Production Area .. 29 Storage Areas .. 31 Quality Control Areas .. 32 Ancillary Areas .. 32 Equipment .. 33 Chapter 4 Documentation .. 34 Principle .. 34 Required Gmp Documentation (By Type) .. 34 Generation And Control Of Documentation .. 35 Good Documentation Practices .. 36 Retention Of Documents .. 37 Specifications .. 38 Specifications For Starting And Packaging Materials .. 38 Specifications For Intermediate And Bulk Products .. 38 Specifications For Finished Products.

3 38 Manufacturing Formula And Processing Instructions .. 39 Packaging Instructions .. 40 Batch Processing Record .. 40 Batch Packaging Record .. 41 Procedures And Records .. 42 Receipt .. 42 Sampling .. 42 Testing .. 43 Other .. 43 Table of contents 6 Chapter 5 Production .. 45 Principle .. 45 General .. 45 Prevention Of Cross-Contamination In Production .. 46 Technical Measures .. 48 Organisational Measures .. 48 Validation .. 49 Starting Materials .. 50 Active Substances .. 50 51 Processing Operations - Intermediate And Bulk Products .. 54 Packaging Materials .. 54 Packaging Operations .. 54 Finished Products .. 56 Rejected, Recovered And Returned Materials .. 57 Chapter 6 Quality Control .. 59 Principle .. 59 General .. 59 Documentation .. 60 Sampling.

4 61 Testing .. 62 On-Going Stability Programme .. 64 Technical Transfer Of Testing Methods .. 66 Chapter 7 Out Sourced Activities .. 68 Principle .. 68 General .. 68 The Contract Giver .. 68 The Contract 69 The Contract .. 70 Chapter 8 Complaints And Product Recall .. 72 Principle .. 72 Personnel And Organisation .. 72 Procedures For Handling And Investigating Complaints Including Possible Quality Defects 73 Investigation And Decision-Making .. 74 Root Cause Analysis And Corrective And Preventative Actions .. 75 Product Recalls And Other Potential Risk-Reducing Actions .. 76 Chapter 9 Self Inspection .. 79 Principle .. 79 Annex 1 Manufacture Of Sterile Medicinal Products .. 80 Table of contents 7 Principle .. 80 General .. 80 Clean Room And Clean Air Device Classification .. 81 Clean Room And Clean Air Device Monitoring .. 82 Isolator Technology .. 85 Blow/Fill/Seal Technology.

5 86 Terminally Sterilised Products .. 86 Aseptic Preparation .. 87 Personnel .. 87 Premises .. 89 Equipment .. 90 Sanitation .. 91 Processing .. 91 Sterilisation .. 94 Sterilisation By Heat .. 95 Moist Heat .. 95 Dry Heat .. 96 Sterilisation By Radiation .. 96 Sterilisation With Ethylene Oxide .. 96 Filtration Of Medicinal Products Which Cannot Be Sterilised In Their Final Container .. 97 Finishing Of Sterile Products .. 98 Quality Control .. 99 Annex 2 Manufacture Of Biological Medicinal Substances And Products For Human Use .. 100 Scope .. 100 Table 1. Illustrative Guide To Manufacturing Activities Within The Scope Of Annex 2 .. 102 Principle .. 104 Part A. General 105 Personnel .. 105 Premise And Equipment .. 106 Animals .. 109 Documentation .. 110 Production .. 111 Starting Materials .. 111 Seed Lot And Cell Bank System .. 114 Operating Principles .. 116 Quality Control.

6 118 Part B. Specific Guidance On Selected Product Types .. 119 Animal Sourced Products .. 119 Allergen Products .. 121 Animal Immunosera Products .. 121 Vaccines .. 122 Recombinant Products .. 122 Monoclonal Antibody Products .. 123 Transgenic Animal Products .. 123 Table of contents 8 Transgenic Plant Products .. 124 Gene Therapy Products .. 125 Somatic And Xenogeneic Cell Therapy Products And Tissue Engineered Products .. 128 Glossary To Annex 129 Annex 3 manufacture of radiopharmaceuticals .. 134 Principle .. 134 Introduction .. 134 Clinical Trials .. 136 Quality Assurance .. 136 Personnel .. 136 Premises And Equipment .. 137 Documentation .. 139 Production .. 139 Quality Control .. 140 Reference And Retention Samples .. 141 Distribution .. 142 Glossary .. 142 Annex 4 Manufacture Of Veterinary Medicinal Products Other Than Immunologicals.

7 143 Manufacture Of Premixes For Medicated Feeding Stuffs .. 143 The Manufacture Of Ectoparasiticides .. 144 The Manufacture Of Veterinary Medicinal Products Containing Penicillins .. 144 Retention Of Samples (Point Viii And Point ) .. 144 Sterile Veterinary Medicinal Products .. 145 Annex 5 Manufacture Of Immunological Veterinary Medical Products .. 146 Principle .. 146 Personnel .. 146 Premises .. 148 Equipment .. 151 Animals And Animal Houses .. 153 Disinfection - Waste Disposal .. 153 Production .. 154 Starting Materials .. 154 Quality Control .. 158 Annex 6 Manufacture Of Medicinal Gases .. 160 Principle .. 160 Personnel .. 162 Premises And Equipment .. 162 Documentation .. 164 Production .. 165 Quality Control .. 169 Transportation Of Packaged Gases .. 171 Glossary .. 171 Table of contents 9 Annex 7 Manufacture Of Herbal Medicinal Products .. 175 Principle.

8 175 Premises .. 177 Storage Areas .. 177 Production Area .. 178 Equipment .. 178 Documentation .. 178 Specifications For Starting Materials .. 178 Annex 8 Sampling Of Starting And Packaging Materials .. 180 Principle .. 180 Personnel .. 180 Starting Materials .. 180 Packaging Material .. 182 Annex 9 Manufacture Of Liquids, Creams And Ointments .. 183 Principle .. 183 Premises And Equipment .. 183 Production .. 183 Annex 10 Manufacture Of Pressurised Metered Dose Aerosol Preparations For Inhalation .. 185 Principle .. 185 General .. 185 Premises And Equipment .. 186 Production And Quality 186 Annex 11 Computerised Systems .. 187 Principle .. 187 General .. 187 Project Phase .. 188 Operational Phase .. 189 Glossary .. 192 Annex 12 Use Of Ionising Radiation In The Manufacture Of Medicinal Products .. 193 Introduction .. 193 Responsibilities .. 193 Dosimetry .. 194 Validation Of The 194 Commissioning Of The 195 Premises.

9 198 Processing .. 199 Gamma Irradiators .. 199 Electron Beam Irradiators .. 200 Documentation .. 200 Microbiological Monitoring .. 201 Annex 13 Manufacture Of Investigational Medicinal Products .. 202 Principle .. 202 Table of contents 10 Glossary .. 204 Quality Management .. 206 Personnel .. 206 Premises And Equipment .. 206 Documentation .. 207 Specifications And Instructions .. 207 Order .. 207 Product Specification File .. 207 Manufacturing Formulae And Processing Instructions .. 208 Packaging 208 Processing, Testing And Packaging Batch Records .. 209 Production .. 209 Packaging Materials .. 209 Manufacturing Operations .. 209 Principles Applicable To Comparator Product .. 210 Blinding Operations .. 210 Randomisation Code .. 210 Packaging .. 211 Labelling .. 211 Quality Control .. 214 Release Of Batches .. 215 Shipping .. 217 Complaints .. 218 Recalls And Returns.

10 218 Recalls .. 218 Returns .. 218 Destruction .. 219 Annex 14 Manufacture Of Medicinal Products Derived From Human Blood Or Plasma .. 221 Contents .. 221 Glossary .. 221 1. Scope .. 223 2. Principles .. 223 3. Quality Management .. 225 4. Traceability And Post Collection Measures .. 227 5. Premises And Equipment .. 229 6. Manufacturing .. 229 7. Quality Control .. 232 8. Release Of Intermediate And Finished Products .. 232 9. Retention Of Plasma Pool Samples .. 233 10. Disposal Of Waste .. 233 Annex 15 Qualification And Validation .. 235 Principle .. 235 General .. 235 1. Organising And Planning For Qualification And Validation .. 236 Table of contents 11 2. Documentation, Including Vmp .. 237 3. Qualification Stages For Equipment, Facilities, Utilities And Systems.. 238 4. Re-Qualification .. 240 5. Process Validation .. 240 6. Verification Of Transportation .. 246 7.