{"product_id":"quality-systems-and-controls-for-pharmaceuticals-9780470056936","title":"Quality Systems and Controls for Pharmaceuticals","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eIn today's global marketplace, particular problems can arise when limited control is exercised over new and high-risk medicines. Providing a multidisciplinary approach,  Quality Systems and Control for Pharmaceuticals  provides a comprehensive overview of the highly regulated area of pharmaceutical manufacture.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003ePreface xi \u003cp\u003eList of figures xv\u003c\/p\u003e \u003cp\u003eList of tables xix\u003c\/p\u003e \u003cp\u003eGlossary of terms and acronyms xxi\u003c\/p\u003e \u003cp\u003eGlossary of mathematical and statistical symbols xxiii\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSECTION A Most Suitable Environment 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1. Introduction 3\u003c\/b\u003e\u003cbr\u003e1.1 The process of finding new lead medicines 4\u003cbr\u003e1.2 A drug discovery framework 6\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2. Technology transfer and the climate of change 11\u003c\/b\u003e\u003cbr\u003e2.1 Innovation and research 11\u003cbr\u003e2.2 Method transfer 14\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3. Quality systems structure and a maximum quality environment 15\u003c\/b\u003e\u003cbr\u003e3.1 The quality gurus and models for assurance 18\u003cbr\u003e3.2 A cycle of continual improvement 22\u003cbr\u003e3.3 Management structure and a functioning department 22\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSECTION B Setting Process Bounderies 29\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4. Validation 31\u003c\/b\u003e\u003cbr\u003e4.1 Process and manufacturing validation activities 35\u003cbr\u003e4.2 Valid analytical methodologies (VAMs) 43\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5. Good manufacturing practices 57\u003c\/b\u003e\u003cbr\u003e5.1 Manufacture of standard products 60\u003cbr\u003e5.2 Manufacture of materials requiring specialised production facilities 75\u003cbr\u003e5.3 Quality assurance aspects of medical gases, devices and miscellaneous product manufacture 88\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6. Process control via numerical means 97\u003c\/b\u003e\u003cbr\u003e6.1 Charting and quality inspection 99\u003cbr\u003e6.2 Sampling plans 104\u003cbr\u003e6.3 Measures of process compliance and variation 108\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7. Product verification and the role of qualified personnel 111\u003c\/b\u003e\u003cbr\u003e7.1 Batch documentation 113\u003cbr\u003e7.2 Standard operating procedures 114\u003cbr\u003e7.3 Guides, overviews and validation plans 115\u003cbr\u003e7.4 The duties of the qualified person 116\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8. In-process and on-process QC testing and control 119\u003c\/b\u003e\u003cbr\u003e8.1 Process analytical technologies 120\u003cbr\u003e8.2 Analytical validation and clinical test validation (CTV) 121\u003cbr\u003e8.3 LIMS and automation 126\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSECTION C Starting from Scratch 131\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9. Applications of QA to new medicinal products and new chemical entities formulation 133\u003c\/b\u003e\u003cbr\u003e9.1 Start-up and initialisation 134\u003cbr\u003e9.2 Raw materials control 134\u003cbr\u003e9.3 The validation life cycle 134\u003cbr\u003e9.4 Top-down or bottom-up validations 135\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10. New products manufacturing 137\u003c\/b\u003e\u003cbr\u003e10.1 From inception to market place 139\u003cbr\u003e10.2 New product development: product design and specification 146\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11. Questions and problems 151\u003c\/b\u003e\u003cbr\u003e11.1 Specimen examples and exam questions 151\u003cbr\u003e11.2 Model answers to examples 162\u003c\/p\u003e \u003cp\u003eReferences 169\u003c\/p\u003e \u003cp\u003eIndex 177\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49402273890647,"sku":"9780470056936","price":53.15,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470056936.jpg?v=1730479911","url":"https:\/\/bookcurl.com\/products\/quality-systems-and-controls-for-pharmaceuticals-9780470056936","provider":"Book Curl","version":"1.0","type":"link"}