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ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
List of ICH Quality Guidelines for Pharmaceutical Industry. Table of Contents. Revised ICH (International Conference on Hormonisation) Quality Guidelines in pharmaceuticals are given below: Q1A (R2) – Stability Testing of New Drug Substances and Products. Q1 B – Stability Testing : Photo Stability Testing of New Drug Substances and Products.
These guidelines (Q2(R2) and Q14) are intended to complement ICH Q8 to Q12 Guidelines, as well as ICH Q13 for Continuous Manufacturing. Date of Step 4 : 1 November 2023
ICH Guideline Database. Search tools are available for easy retrieval of information on ICH Guidelines: Index of ICH Guidelines by keyword, status and date; Status of Implementation of ICH Guidelines by ICH Members
You can explore in the below table the index of all ICH Guidelines, finalised or under development, on the topics of Quality, Safety, Efficacy and Multidisciplinary. Please select first the relevant topic. You can then search by ICH Step status, date, and/or by keyword.
The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. Title. Q1A - Q1F Stability. Accordions. Title.
The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
1 – Stability Testing. set of originally five guidelines (Q1A to Q1F) defining. General aspects of stability testing (storage conditions, batch size and number, length of time...) Photostability. Application to new dosage forms. Possibilities for reduced test designs (bracketing and matrixing) 1 – Stability Testing.
The concepts outlined in prior ICH Quality Guidelines (ICH Q8 (R2), Q9, Q10 and Q11) provide opportunities for science- and riskbased approaches - for use in drug development and regulatory decisions.
