Quality Systems and Controls for Pharmaceuticals

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.

Quality Systems and Control for Pharmaceuticals is anaccessible overview of the highly-regulated area of pharmaceuticalmanufacture, the production of biomedical materials, and biomedicaldevices. Introducing the subject in a clear and logical manner itenables the reader to grasp the key concepts of themultidisciplinary area of control science and specifically qualitycontrol using industrial and theoretical models.Taking a multidisciplinary approach to the subject the reader isguided through key topics such as product safety which takes intoaccount aspects of analytical science, statistics, microbiologybiotechnology, engineering, business practice and optimizingmodels, the law and safeguarding public health, innovation andinventiveness and contemporary best practice.The author has both industry and academic experience and many'best practice' examples are included throughout thetext based on his own industry experience and current practicingindustrial pharmacists. This is an invaluable reference for allstudents of pharmacy who may have little or no familiarity withindustrial practice and for those studying BSc chemistrybiomedical sciences, process analytical chemistry and MSc inIndustrial Practice.

Preface xiList of figures xvList of tables xixGlossary of terms and acronyms xxiGlossary of mathematical and statistical symbols xxiiiSECTION A Most Suitable Environment 11. Introduction 31.1 The process of finding new lead medicines 41.2 A drug discovery framework 62. Technology transfer and the climate of change 112.1 Innovation and research 112.2 Method transfer 143. 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 22SECTION B Setting Process Bounderies 294. Validation 314.1 Process and manufacturing validation activities 354.2 Valid analytical methodologies (VAMs) 435. 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 886. Process control via numerical means 976.1 Charting and quality inspection 996.2 Sampling plans 1046.3 Measures of process compliance and variation 1087. 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 1168. 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 126SECTION C Starting from Scratch 1319. 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 13510. New products manufacturing 13710.1 From inception to market place 13910.2 New product development: product design and specification 14611. Questions and problems 15111.1 Specimen examples and exam questions 15111.2 Model answers to examples 162References 169Index 177