Table of Contents
Preface xi
List of figures xv
List of tables xix
Glossary of terms and acronyms xxi
Glossary of mathematical and statistical symbols xxiii
SECTION A Most Suitable Environment 1
1. Introduction 31.1 The process of finding new lead medicines 41.2 A drug discovery framework 6
2. Technology transfer and the climate of change 112.1 Innovation and research 112.2 Method transfer 14
3. Quality systems structure and a maximum quality environment 153.1 The quality gurus and models for assurance 183.2 A cycle of continual improvement 223.3 Management structure and a functioning department 22
SECTION B Setting Process Bounderies 29
4. Validation 314.1 Process and manufacturing validation activities 354.2 Valid analytical methodologies (VAMs) 43
5. Good manufacturing practices 575.1 Manufacture of standard products 605.2 Manufacture of materials requiring specialised production facilities 755.3 Quality assurance aspects of medical gases, devices and miscellaneous product manufacture 88
6. Process control via numerical means 976.1 Charting and quality inspection 996.2 Sampling plans 1046.3 Measures of process compliance and variation 108
7. Product verification and the role of qualified personnel 1117.1 Batch documentation 1137.2 Standard operating procedures 1147.3 Guides, overviews and validation plans 1157.4 The duties of the qualified person 116
8. In-process and on-process QC testing and control 1198.1 Process analytical technologies 1208.2 Analytical validation and clinical test validation (CTV) 1218.3 LIMS and automation 126
SECTION C Starting from Scratch 131
9. Applications of QA to new medicinal products and new chemical entities formulation 1339.1 Start-up and initialisation 1349.2 Raw materials control 1349.3 The validation life cycle 1349.4 Top-down or bottom-up validations 135
10. New products manufacturing 13710.1 From inception to market place 13910.2 New product development: product design and specification 146
11. Questions and problems 15111.1 Specimen examples and exam questions 15111.2 Model answers to examples 162
References 169
Index 177