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Summary
Summary
Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models.
Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice.
The author has both industry and academic experience and many 'best practice' examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.
Author Notes
Dipak K. Sarker, School of Pharmacy and Biomolecular Sciences University of Brighton, UK
Table of Contents
| Preface | p. xi |
| List of figures | p. xv |
| List of tables | p. xix |
| Glossary of terms and acronyms | p. xxi |
| Glossary of mathematical and statistical symbols | p. xxiii |
| Section A Most Suitable Environment | p. 1 |
| 1 Introduction | p. 3 |
| 1.1 The process of finding new lead medicines | p. 4 |
| 1.2 A drug discovery framework | p. 6 |
| 2 Technology transfer and the climate of change | p. 11 |
| 2.1 Innovation and research | p. 11 |
| 2.2 Method transfer | p. 14 |
| 3 Quality systems structure and a maximum quality environment | p. 15 |
| 3.1 The quality gurus and models for assurance | p. 18 |
| 3.2 A cycle of continual improvement | p. 22 |
| 3.3 Management structure and a functioning department | p. 22 |
| Section B Setting Process Bounderies | p. 29 |
| 4 Validation | p. 31 |
| 4.1 Process and manufacturing validation activities | p. 35 |
| 4.2 Valid analytical methodologies (VAMs) | p. 43 |
| 5 Good manufacturing practices | p. 57 |
| 5.1 Manufacture of standard products | p. 60 |
| 5.2 Manufacture of materials requiring specialised production facilities | p. 75 |
| 5.3 Quality assurance aspects of medical gases, devices and miscellaneous product manufacture | p. 88 |
| 6 Process control via numerical means | p. 97 |
| 6.1 Charting and quality inspection | p. 99 |
| 6.2 Sampling plans | p. 104 |
| 6.3 Measures of process compliance and variation | p. 108 |
| 7 Product verification and the role of qualified personnel | p. 111 |
| 7.1 Batch documentation | p. 113 |
| 7.2 Standard operating procedures | p. 114 |
| 7.3 Guides, overviews and validation plans | p. 115 |
| 7.4 The duties of the qualified person | p. 116 |
| 8 In-process and on-process QC testing and control | p. 119 |
| 8.1 Process analytical technologies | p. 120 |
| 8.2 Analytical validation and clinical test validation (CTV) | p. 121 |
| 8.3 LIMS and automation | p. 126 |
| Section C Starting from Scratch | p. 131 |
| 9 Applications of QA to new medicinal products and new chemical entities formulation | p. 133 |
| 9.1 Start-up and initialisation | p. 134 |
| 9.2 Raw materials control | p. 134 |
| 9.3 The validation life cycle | p. 134 |
| 9.4 Top-down or bottom-up validations | p. 135 |
| 10 New products manufacturing | p. 137 |
| 10.1 From inception to market place | p. 139 |
| 10.2 New product development: product design and specification | p. 146 |
| 11 Questions and problems | p. 151 |
| 11.1 Specimen examples and exam questions | p. 151 |
| 11.2 Model answers to examples | p. 162 |
| References | p. 169 |
| Index | p. 177 |
