Making Quality Cosmetics: Good Manufacturing Practice and ISO 22716:2007

Cosmetics manufacture is a dynamic and vibrant industry with companies varying from the very small scale, working in their own home, to much larger enterprises. With such variable companies there is the risk of equally variable quality in manufacturing. The International Organization for Standards (ISO) provides guidelines on good manufacturing processes for the cosmetics industry. However, not everyone working in cosmetics has a scientific or engineering backgrounds and understanding and meeting the ISO requirements can be daunting.

Whether you are a small business just starting out or an established company looking to expand, Making Quality Cosmetics will guide you through the requirements of the ISO standard. Calling on more than 35 years of experience in the cosmetics sector the author covers every aspect of the manufacturing set up and process, as well as discussing other regulations that may need to be considered, especially in larger facilities. With technical advice ranging from choosing equipment and raw materials, to assessing and auditing contractors this book will help you make sure your products are of the highest quality.

Contents
Chapter 1 Introduction 1
Chapter 2 Personnel 3
2.1 Management Responsibilities 3
2.2 Typical Roles 5
2.3 Personnel Responsibilities 6
2.4 Training 7
2.4.1 Training Evaluation 7
2.4.2 Training Records 8
2.5 Personnel Hygiene 8
2.6 Personnel Health 8
2.7 Visitors and Untrained Personnel 10
Reference 10
Chapter 3 Premises 11
3.1 Layout 12
3.2 Buildings 15
3.3 Health and Safety 15
3.3.1 Hazardous Materials 16
3.4 Finishes 16
3.4.1 Building Within a Building 17
3.4.2 General 17
3.4.3 Walls 18
3.4.4 Windows 20
3.4.5 Doors 21
3.4.6 Floors 22
3.4.7 Interface Between Floors and Walls 25
3.4.8 Mezzanine Platforms 26
3.4.9 Ceilings 28
3.4.10 Lighting 29
3.4.11 Drains 29
3.5 Heating, Cooling and Ventilation 32
3.5.1 Ventilation 32
3.5.2 Temperature Control 33
3.5.3 Humidity Control 33
3.5.4 Pressure Control 34
3.5.5 Heating and Cooling Systems 34
3.5.6 Local Exhaust Ventilation 36
3.6 Utilities 38
3.6.1 Electrical Supply 38
3.6.2 Water Systems 39
3.6.3 Compressed Air 54
3.6.4 Vacuum 59
3.6.5 Labelling Pipework 62
3.7 Cleaning 63
3.8 Pest Control 63
3.9 Fire Alarm Systems 63
3.10 Maintenance 64
3.11 Security 64
References 64
Chapter 4 Equipment 66
4.1 General 66
4.2 Microbiological Control Strategy 66
4.3 Materials of Construction 68
4.3.1 Stainless Steel 68
4.3.2 Steel 
4.3.3 Plastics and Polymers 73
4.3.4 Polymer Gaskets and Seals 73
4.3.5 Polymer Pipework 74
4.3.6 Hoses 75
4.3.7 Glass 77
4.4 Cleaning and Sanitisation of Equipment 77
4.4.1 Equipment Drain-ability 78
4.4.2 Equipment Clean-ability 80
4.4.3 Process Pipework Connections 81
4.4.4 Valves 84
4.4.5 Product Recovery 90
4.4.6 Manual Cleaning 91
4.5 Clean in Place 92
4.6 Off-line Cleaning 96
4.7 Cleaning Validation 97
4.8 Eliminating Water from Process Equipment 97
4.9 Disposable Technology 98
4.10 Product Development Laboratory 98
4.10.1 Product Development Laboratory
Design 99
4.10.2 Product Development Laboratory
Basic Equipment 99
4.10.3 Overhead Stirrers 101
4.10.4 Hotplates and Magnetic Stirrers 103
4.10.5 High Shear Mixers (Dispersers) 104
4.10.6 pH Meter 105
4.10.7 Viscometer 106
4.10.8 Digital Thermometer 107
4.10.9 Pycnometer 108
4.10.10 Water Bath 108
4.10.11 Stability Testing Storage Chambers 108
4.10.12 Light Box or Lightbooth 109
4.10.13 Purified Water System 110
4.10.14 Parts Washer 110
4.11 Weighing Equipment 110
4.12 Instruments and Calibration 112
4.13 Mixing Systems 112
4.13.1 Mechanical Seals 113
4.13.2 Mixer Manways 114
4.13.3 Raw Material Addition Ports 115
4.13.4 High Shear Mixers 116
4.13.5 Mixers for Liquids, Creams and
Semi-solids 118
4.13.6 Powder Mixers 123
4.13.7 Mixer Size 124
4.14 Storage Tanks 126
4.15 Transfer Pumps 127
4.15.1 Diaphragm Pumps 128
4.15.2 Rotary Lobe Pumps 129
4.15.3 Centrifugal Pump 130
4.15.4 Sine Pump 130
4.15.5 Peristaltic Pumps 131
4.15.6 Powder Pumps 131
4.16 Filtration of Batches 132
4.17 Filling 133
4.17.1 Manual Filling 134
4.17.2 Manual Filling Equipment 134
4.17.3 Semi-automatic Filling Equipment 135
4.17.4 Level Filling 136
4.17.5 Powder Filling 136
4.17.6 Automatic Filling Equipment 137
4.18 Capping, Sealing and Crimping 138
4.18.1 Capping 138
4.18.2 Crimping 141
4.18.3 Tube Filling, Sealing and Crimping 142
4.18.4 Plastic and Laminate Tube Sealing 142
4.18.5 Tube Crimping 144
4.18.6 Monobloc Machines 144
4.19 Filling Tottles or Unstable Packs 145
4.20 Labelling 146
4.20.1 Print and Apply Labelling 147
4.20.2 Labelling Round Containers 148
4.20.3 Labelling Flat or Oval Containers 148
4.21 Cartoning 149
4.22 Overwrapping 150
4.23 Batch Coding 152
4.24 Tamper-evident Seals 155
4.25 Outer Packaging 155
4.26 Packaging Lines 156
4.27 Aerosol Manufacture 157
4.28 Colour Cosmetics 158
4.28.1 Lipsticks 159
4.28.2 Pressed and Baked Powders 160
4.28.3 Nail Enamels 164
4.29 Soap Manufacture 165
4.30 Continuous Manufacturing and Common
Base Production 166
4.31 Specifying Equipment 169
References 170
Chapter 5 Raw Materials and Packaging Components 172
5.1 Raw Material and Packaging Materials Supply 172
5.1.1 Raw Materials 172
5.1.2 Packaging Materials 173
5.2 Purchasing Raw Material and Packaging Materials 173
5.2.1 Raw Material Naming and Code Numbers 174
5.2.2 Packaging Material Descriptions and
Code Numbers 175
5.3 Receiving Materials 176
5.4 Materials Release 176
5.5 Material Storage 177
5.6 Re-evaluation of Materials 178
5.7 Material Handling Equipment 178
5.7.1 Raw Material Handling 179
5.7.2 Liquid Raw Material Containers 179
5.7.3 Intermediate Bulk Containers 187
5.7.4 Solid Raw Material Handling Equipment 188
5.8 Bulk Storage 189
5.8.1 Measuring the Quantity of a Bulk Raw Material 193
5.8.2 Dilution of High Active Surfactants 195
5.8.3 Examples of Bulk Storage Installations for
Commonly Used Raw Materials 195
5.9 Bulk Storage of Powder Raw Materials 203
5.10 Mini-bulk Storage 205
5.11 Packaging Components 206
Chapter 6 Manufacturing and Packaging Operations 207
6.1 Documentation 207
6.2 Manufacturing Operations 208
6.2.1 Batch Numbers 209
6.2.2 Product Master Formulation 209
6.2.3 Bill of Materials 210
6.2.4 Approved Raw Material Supplier List 211
6.2.5 Batch Control Record 212
6.2.6 Finished Product Specification 214
6.2.7 Analytical Methods 215
6.2.8 Standard Operating Procedures 219
6.2.9 Approved Equipment List 222
6.2.10 Start-up Checks 222
6.2.11 Identification of Raw Materials and
Intermediates 222
6.2.12 In-process Control 222
6.2.13 Bulk Product Storage 223
6.2.14 Restocking of Raw Materials 224
6.3 Packaging Operations 224
6.3.1 Documentation 225
6.3.2 Pack Formats 225
6.3.3 Batch Number 225
6.3.4 Start-up Checks 226
6.3.5 Line Clearance and Start-up Checklist 228
6.3.6 Packaging Method 229
6.3.7 Filling and Packaging Quality Checks 232
6.3.8 Fill Checks 233
6.3.9 On-line Control Equipment 234
6.3.10 Restocking of Packaging Materials 234
6.3.11 Identification and Handling of Work in
Process 234
Chapter 7 Finished Products 235
7.1 Product Release 235
7.2 Storage 238
7.3 Shipment 239
7.4 Returns 239
Chapter 8 Quality Control and Quality Assurance 240
8.1 Quality Assurance 240
8.2 Quality Control 240
8.2.1 Test Methods 241
8.2.2 Acceptance Criteria 241
8.2.3 Out-of-Specification Results 242
8.2.4 Quality Control Laboratory Equipment 242
8.2.5 Microbiological Testing 243
8.2.6 Reagents, Solutions, Reference Standards,
Culture Media 245
8.2.7 Sampling 245
8.2.8 Samples for Microbiology Testing 248
8.2.9 Labelling Samples 248
8.3 Retained Samples 248
8.3.1 Finished Product Retained Samples 249
8.3.2 Raw Material Retained Samples 249
8.3.3 Component Samples 249
8.3.4 Disposal of Retained Samples 249
8.4 Reduced Testing 249
Chapter 9 Waste 251
9.1 Reducing Waste 253
Chapter 10 Sub-contracting 255
10.1 Types of Sub-contracting 256
10.2 Contract 256
10.3 Contract Giver 256
10.4 Contract Acceptor 257
Chapter 11 Non-conformances, Deviations and Corrective and
Preventative Actions (CAPA) 258
11.1 Non-conformance 258
11.2 Deviation 258
11.3 CAPA 259
11.4 Recording and Handling Non-conformances 259
11.5 Recording and Handling Deviations 260
11.6 Recording and Handling Corrective and
Preventative Actions 262
11.6.1 Identifying Improvements 264
Chapter 12 Complaints, Recalls and Adverse Reactions 265
12.1 Complaints 265
12.2 Recalls 267
12.3 Adverse Reactions 269
Chapter 13 Change Control 270
13.1 Approving Changes 270
13.2 The Impact and Time Taken to Implement Change 272
13.3 Example of a Change 272
13.4 Document Review and Approval 273
13.5 Obsolete Documents 273
Chapter 14 Audits 274
14.1 Internal Audits 274
14.2 External Audits 274
14.3 Supplier Audits 275
14.4 Sub-contractor Audits 275
14.5 Health and Safety Audits 275
14.6 Environmental Audits 276
14.7 Loss Prevention Audits 276
Chapter 15 Documentation 277
15.1 Documents Required in a Cosmetics Facility 277
15.2 Document Distribution 277
15.3 Document Revisions 279
15.4 Handwritten Entries 279
15.5 Archiving Documents 280
15.6 Document Retention Policy 280
Chapter 16 Health and Safety and Environment 281
16.1 Health and Safety Regulations to
Protect Employees 282
16.1.1 Health and Safety at Work 282
16.1.2 Working with Hazardous Substances 282
16.1.3 Other Legislation and Guidelines to be
Considered 283
16.2 Health and Safety Regulations to
Protect Facilities 283
16.3 The Environment 283
Chapter 17 Other Legislation 285
Chapter 18 Afterword and the 10 Golden Rules of GMP 287
Subject Index 289