{"product_id":"ich-quality-guidelines-isbn-9781118971116","title":"ICH Quality Guidelines","description":"Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.\u003cbr\u003e\u003cbr\u003e•    Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies\u003cbr\u003e•    Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines\u003cbr\u003e•    Uses case studies to help readers understand and apply ICH guidelines\u003cbr\u003e•    Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines\u003cbr\u003e•    Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP) \u003cp\u003eList of Contributors ix\u003c\/p\u003e \u003cp\u003eAn Introduction to ICH Quality Guidelines: Opportunities and Challenges 1\u003c\/p\u003e \u003cp\u003e1 ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms 3\u003cbr\u003e \u003ci\u003eAndy Rignall\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Stability Testing: Photostability Testing of New Drug Substances and Products ICH Q1B 45\u003cbr\u003e \u003ci\u003eDavid Clapham\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 73\u003cbr\u003e \u003ci\u003eRaymond Peter Munden\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 ICH Q1E Evaluation for Stability Data 89\u003cbr\u003e \u003ci\u003eGarry Scrivens\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Q2(R1) Validation of Analytical Procedures: Text and Methodology 127\u003cbr\u003e \u003ci\u003ePhillip Borman and David Elder\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Impurities in New Drug Substances and New Drug Products: ICH Q3A\/B: Key Guidelines in the General Impurity Management Process 167\u003cbr\u003e \u003ci\u003eAndrew Teasdale, David Elder, James Harvey, and Steven Spanhaak\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 ICH Q3C Impurities: Guideline for Residual Solvents 199\u003cbr\u003e \u003ci\u003eJohn Connelly\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 ICH Q3D Elemental Impurities 233\u003cbr\u003e \u003ci\u003eAndrew Teasdale and Sarah Thompson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 ICH Q4: Pharmacopeial Harmonization and Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions 281\u003cbr\u003e \u003ci\u003eDavid Elder\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 ICH Q5A: Viral Safety of Biotechnology Products 311\u003cbr\u003e \u003ci\u003eDaniel Galbraith\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 ICH Q5B Analysis of the Expression Construct in Cell Lines Used for Production of Recombinant DNA‐Derived Protein Products 337\u003cbr\u003e \u003ci\u003eJianxin Ye, Zhong Liu, and David Pollard\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 ICH Q5C Stability Testing of Biotechnological\/Biological Products 345\u003cbr\u003e \u003ci\u003eJohn G. Davies, Di Gao, Yoen Joo Kim, Richard Harris, Patricia W. Cash, Timothy L. Schofield, Roujian Zhang, and Qiang Qin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Q5D Derivation and Characterization of Cell Substrates Used for Production ofBiotechnological\/Biological Products 375\u003cbr\u003e \u003ci\u003eMark Plavsic\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Conduct of Risk Assessments: An Integral Part of Compliance with ICH Q5A and ICH Q5D 395\u003cbr\u003e \u003ci\u003eRaymond W. Nims\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 ICH Q5E Comparability of Biotechnological\/Biological Products Subject to Changes in Their Manufacturing Processes: Summary and Analysis of ICH Q5E Guideline 409\u003cbr\u003e \u003ci\u003eRamani R. Raghavan and Robert McCombie\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances 433\u003cbr\u003e \u003ci\u003eDavid Elder\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17 ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological\/Biological Products 467\u003cbr\u003e \u003ci\u003eScott R. Rudge and Raymond W. Nims\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18 Process‐Related Impurities in Biopharmaceuticals: A Deeper Dive into Ich Q6b 487\u003cbr\u003e \u003ci\u003eAnil Raghani, Kim Li, Jeanine L. Bussiere, Joel P. Bercu, and Jinshu Qiu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs) 509\u003cbr\u003e \u003ci\u003eGordon Munro\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Q8(R2): Pharmaceutical Development 535\u003cbr\u003e \u003ci\u003ePer Holm, Morten Allesø, Mette C. Bryder, and René Holm\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 ICH Q9 Quality Risk Management 579\u003cbr\u003e \u003ci\u003eDavid Elder and Andrew Teasdale\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 ICH Q10 Quality Systems: ICH Q10 Implementation at Genentech\/Roche 611\u003cbr\u003e \u003ci\u003eLarry Wigman and Danny Ooi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 ICH Q11: Development and Manufacture of Drug Substance 639\u003cbr\u003e \u003ci\u003eRonald Ogilvie\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24 ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk 667\u003cbr\u003e \u003ci\u003eAndrew Teasdale\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 701 \u003c\/p\u003e \u003cp\u003e\u003cb\u003e Andrew Teasdale, PhD,\u003c\/b\u003e is a principal scientist in pharmaceutical development with AstraZeneca. He has over 20 years' experience within the industry and has held a number of leadership roles both internally and externally at a cross industry level encompassing key ICH topic areas.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e David Elder, PhD,\u003c\/b\u003e is an independent CMC consultant. He has 40 years' experience within the pharmaceutical industry. He was formerly a director within GlaxoSmithKline's platform technology and science function. He is an expert member for the British Pharmacopoeia and has extensive CMC experience encompassing many of the key ICH topics.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e Raymond W. Nims, PhD,\u003c\/b\u003e is a Senior Consultant at RMC Pharmaceutical Solutions, with experience in a variety of GMP quality assurance and quality control topics from a biologics point of reference. He has served on ad hoc panels supporting a number of USP chapters and ANSI Standards.\u003c\/p\u003e   \u003cp\u003e In 1989, global regulatory authorities in the United States, Europe, and Japan – together with pharmaceutical trade associations from the same regions – established an International Conference on Harmonization (ICH) to standardize the quality and safety requirements for drug product registration. Through the ICH process, more than fifty guidelines have been produced covering quality, non-clinical safety, clinical efficacy and safety, and multi-disciplinary topics. While the guidelines provide a clear framework in terms of requirements, there remains the necessity to interpret how compliance can be achieved practically. Interpreting and implementing the ICH quality guidelines from a practical point of view is thus a challenge facing the entire pharmaceutical industry.   \u003c\/p\u003e\u003cp\u003e Motivated by the pressing need for a consistent and integrated view of how the guidelines inform drug development strategic planning and decision-making, \u003ci\u003eICH Quality Guidelines: An Implementation Guide\u003c\/i\u003e focuses on the quality guidelines and requirements along with their implications and practical implementation. Featuring chapters by authors who were involved in the development of the guidelines and subject matter experts, the book offers a succinct and definitive text with practical case study examples.   \u003c\/p\u003e\u003cp\u003e Topics include stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP). The book provides a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of the guidelines, giving not only a definitive narrative, but also actual solutions to effectively manage the associated identified issues.   \u003c\/p\u003e\u003cp\u003e Encompassing both R\u0026amp;D and marketing environments, \u003ci\u003eICH Quality Guidelines\u003c\/i\u003e details the appropriate application during the phases of drug development – a truly global issue and thus valuable to anyone involved in the pharma industry throughout the world.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989397749989,"sku":"NP9781118971116","price":374.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118971116.jpg?v=1761783952","url":"https:\/\/k12savings.com\/products\/ich-quality-guidelines-isbn-9781118971116","provider":"K12savings","version":"1.0","type":"link"}