Skip to main content

ICH Quality Guidelines: An Implementation Guide

ICH Quality Guidelines: An Implementation Guide

Andrew Teasdale, David Elder, Raymond W. Nims

ISBN: 978-1-118-97111-6

Oct 2017

736 pages

In Stock

$350.00

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.

•    Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies
•    Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines
•    Uses case studies to help readers understand and apply ICH guidelines
•    Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines
•    Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

List of Contributors

Chapter 1: ICHQ1A(R2) STABILITY TESTING OF NEW DRUG SUBSTANCE AND PRODUCT, ICHQ1C STABILITY TESTING OF NEW DOSAGE FORMS

Chapter 2: ICH Q1B STABILITY TESTING: PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

Chapter 3: ICH Q1D THE EFFICIENT DESIGN OF STABILITY PROTOCOLS - BRACKETING AND MATRIXING  

Chapter 4: ICH Q1E EVALUATION FOR STABILITY DATA

Chapter 5: ICH Q2 VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY

Chapter 6: ICH Q3A / Q3B IMPURITIES IN NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: KEY IN THE GENERAL IMPURITY MANAGEMENT PROCESS

Chapter 7: ICH Q3C IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS

Chapter 8: ICH Q3D ELEMENTAL IMPURITIES

Chapter 9: ICH Q4 PHARMACOPOEIAL HARMONIZATION

Chapter 10: ICH Q5A VIRAL SAFETY OF BIOTECHNOLOGY PRODUCTS

Chapter 11: ICH Q5B ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELL LINES USED FOR PRODUCTION OF RECOMBINANT-DNA-DERIVED PROTEIN PRODUCTS

Chapter 12: ICH Q5C STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS

Chapter 13: ICH Q5D DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS 

Chapter 14: CONDUCT OF RISK ASSESSMENTS: AN INTEGRAL PART OF COMPLIANCE WITH ICH Q5A AND ICH Q5D

Chapter 15: ICH Q5E COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESSES - SUMMARY AND ANALYSIS OF ICH Q5E GUIDELINE

Chapter 16: ICH Q6A SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES

Chapter 17: ICH Q6B SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS

Chapter 18: PROCESS-RELATED IMPURITIES IN BIOPHARMACEUTICALS – A DEEPER DIVE INTO ICH Q6B

Chapter 19: ICH Q7- GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS (APIs)

Chapter 20: ICH Q8 PHARMACEUTICAL DEVELOPMENT

Chapter 21: ICH Q9 QUALITY RISK MANAGEMENT

Chapter 22: ICH Q10 A PHARMACEUTICAL QUALITY SYSTEM STRATEGY FOR A GLOBALLY DIVERSE COMPANY

Chapter 23: ICH Q11 – DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCE          

Chapter 24: ICH M7 - ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK

Index