Ich Quality Guidelines -

. .

Editeur : John Wiley & Sons

Langue : Anglais

Parution : 01/10/2017

Format : Moyen, de 350g à 1kg

Nombre de pages : 736

Expédition : 1200

Dimensions : 23.5 x 15.7 x 4.4

ISBN : 9781118971116

Résumé :
.

Biographie:

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.

Sommaire:
List of Contributors ix An Introduction to ICH Quality Guidelines: Opportunities and Challenges 1 1 ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms 3 Andy Rignall 2 Stability Testing: Photostability Testing of New Drug Substances and Products ICH Q1B 45 David Clapham 3 ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 73 Raymond Peter Munden 4 ICH Q1E Evaluation for Stability Data 89 Garry Scrivens 5 Q2(R1) Validation of Analytical Procedures: Text and Methodology 127 Phillip Borman and David Elder 6 Impurities in New Drug Substances and New Drug Products: ICH Q3A/B: Key Guidelines in the General Impurity Management Process 167 Andrew Teasdale, David Elder, James Harvey, and Steven Spanhaak 7 ICH Q3C Impurities: Guideline for Residual Solvents 199 John Connelly 8 ICH Q3D Elemental Impurities 233 Andrew Teasdale and Sarah Thompson 9 ICH Q4: Pharmacopeial Harmonization and Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions 281 David Elder 10 ICH Q5A: Viral Safety of Biotechnology Products 311 Daniel Galbraith 11 ICH Q5B Analysis of the Expression Construct in Cell Lines Used for Production of Recombinant DNA?]Derived Protein Products 337 Jianxin Ye, Zhong Liu, and David Pollard 12 ICH Q5C Stability Testing of Biotechnological/Biological Products 345 John G. Davies, Di Gao, Yoen Joo Kim, Richard Harris, Patricia W. Cash, Timothy L. Schofield, Roujian Zhang, and Qiang Qin 13 Q5D Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products 375 Mark Plavsic 14 Conduct of Risk Assessments: An Integral Part of Compliance with ICH Q5A and ICH Q5D 395 Raymond W. Nims 15 ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Processes: Summary and Analysis of ICH Q5E Guideline 409 Ramani R. Raghavan and Robert McCombie 16 ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances 433 17 ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 467 Scott R. Rudge and Raymond W. Nims 18 Process?]Related Impurities in Biopharmaceuticals: A Deeper Dive into ICH Q6B 487 Anil Raghani, Kim Li, Jeanine L. Bussiere, Joel P. Bercu, and Jinshu Qiu 19 ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs) 509 Gordon Munro 20 Q8(R2): Pharmaceutical Development 535 Per Holm, Morten Alles?, Mette C. Bryder, and Ren? Holm 21 ICH Q9 Quality Risk Management 579 David Elder and Andrew Teasdale 22 ICH Q10 Quality Systems: ICH Q10 Implementation at Genentech/Roche 611 Larry Wigman and Danny Ooi 23 ICH Q11: Development and Manufacture of Drug Substance 639 Ronald Ogilvie 24 ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk 667 Andrew Teasdale Index 701