ICH: GLOBAL STANDARDS FOR PHARMACEUTICAL QUALITY

In the context of globalization, the demand for high-quality pharmaceuticals is increasing, especially as new diseases emerge and drug manufacturing processes become more diverse. To meet the stringent requirements for quality, safety, and efficacy, the ICH organization was established to harmonize pharmaceutical regulations worldwide. This guidelines not only accelerate the process of bringing new drugs to market but also ensure that pharmaceutical products consistently meet the highest quality standards, thereby earning the trust of patients globally.

1. Introduction

ICH (International Council for Harmonization) is an international non-profit organization that creates harmonized guidelines for global pharmaceutical development. Founded in April 1990, ICH’s founding members include Europe, the United States, and Japan.

The goal of ICH was, and still is, the promotion of public health through international harmonization that contributes to:

Prevention of unnecessary duplication of clinical trials and postmarket clinical evaluations
Development and manufacturing of new medicines
Registration and supervision of new medicines without compromising safety and effectiveness.

2. Overview

The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories:

Quality (Q1-Q14): Provides guidelines to ensure product quality, such as stability studies (Q1), setting appropriate impurity thresholds (Q3), and guidelines for Good Manufacturing Practice (GMP) (Q7), etc.
Safety (S1-S13): Offers comprehensive safety guidelines to identify potential risks such as carcinogenicity, genotoxicity, and reproductive toxicity.
Efficacy (E1-E22): Involves the design, implementation, and reporting of clinical trials to ensure that the drug achieves the expected therapeutic efficacy.
Multidisciplinary (M1-M15): Covers issues not specifically related to quality, safety, or efficacy. Includes common medical terminology (MedDRA), the Common Technical Document (CTD), guidelines on genotoxic impurities, bioequivalence waivers (Biowaiver), etc

3. Recent Highlights

In recent ICH guidelines, QbD (Quality by Design) is mentioned as a core concept. Rather than only controlling quality at the final stage, QbD encourages a more proactive approach, where product quality is built into the initial design stage. The trio of guidelines Q8, Q9, and Q10 (Q-Trio) forms a comprehensive quality management system, wherein:

Q8: Pharmaceutical Development – Provides guidance on science-based pharmaceutical development, focusing on QbD. It encourages manufacturers to deeply understand their products and use this knowledge to design efficient and reliable manufacturing processes.
Q9: Quality Risk Management – Provides guidance on managing risks related to product quality. Emphasizes the importance of identifying, evaluating, and controlling potential risks throughout the product lifecycle.
Q10: Pharmaceutical Quality System – Builds a comprehensive quality management system based on Q8 and Q9. Integrates the concepts of QbD and risk management to create a flexible and efficient quality system.

Additionally, Q12: Lifecycle Management has been added to provide tools for managing the product lifecycle, including post-approval changes, allowing manufacturers to adapt flexibly to changes and improvements.

ICH guidelines not only help ensure product quality but also create a common quality system for the global pharmaceutical industry. This helps minimize differences between the regulations of various countries, facilitating international trade and protecting consumer health.

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