ICH Quality Guidelines

Andrew Teasdale, PhD, 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.David Elder, PhD, 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.Raymond W. Nims, PhD, 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.

• List of Contributors ixAn Introduction to ICH Quality Guidelines: Opportunities and Challenges 11 ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms 3Andy Rignall2 Stability Testing: Photostability Testing of New Drug Substances and Products ICH Q1B 45David Clapham3 ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 73Raymond Peter Munden4 ICH Q1E Evaluation for Stability Data 89Garry Scrivens5 Q2(R1) Validation of Analytical Procedures: Text and Methodology 127Phillip Borman and David Elder6 Impurities in New Drug Substances and New Drug Products: ICH Q3A/B: Key Guidelines in the General Impurity Management Process 167Andrew Teasdale, David Elder, James Harvey, and Steven Spanhaak7 ICH Q3C Impurities: Guideline for Residual Solvents 199John Connelly8 ICH Q3D Elemental Impurities 233Andrew Teasdale and Sarah Thompson9 ICH Q4: Pharmacopeial Harmonization and Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions 281David Elder10 ICH Q5A: Viral Safety of Biotechnology Products 311Daniel Galbraith11 ICH Q5B Analysis of the Expression Construct in Cell Lines Used for Production of Recombinant DNA‐Derived Protein Products 337Jianxin Ye, Zhong Liu, and David Pollard12 ICH Q5C Stability Testing of Biotechnological/Biological Products 345John G. Davies, Di Gao, Yoen Joo Kim, Richard Harris, Patricia W. Cash, Timothy L. Schofield, Roujian Zhang, and Qiang Qin13 Q5D Derivation and Characterization of Cell Substrates Used for Production ofBiotechnological/Biological Products 375Mark Plavsic14 Conduct of Risk Assessments: An Integral Part of Compliance with ICH Q5A and ICH Q5D 395Raymond W. Nims15 ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Processes: Summary and Analysis of ICH Q5E Guideline 409Ramani R. Raghavan and Robert McCombie16 ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances 433David Elder17 ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 467Scott R. Rudge and Raymond W. Nims18 Process‐Related Impurities in Biopharmaceuticals: A Deeper Dive into Ich Q6b 487Anil Raghani, Kim Li, Jeanine L. Bussiere, Joel P. Bercu, and Jinshu Qiu19 ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs) 509Gordon Munro20 Q8(R2): Pharmaceutical Development 535Per Holm, Morten Allesø, Mette C. Bryder, and René Holm21 ICH Q9 Quality Risk Management 579David Elder and Andrew Teasdale22 ICH Q10 Quality Systems: ICH Q10 Implementation at Genentech/Roche 611Larry Wigman and Danny Ooi23 ICH Q11: Development and Manufacture of Drug Substance 639Ronald Ogilvie24 ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk 667Andrew TeasdaleIndex 701