Certified Pharmaceutical GMP Professional Practice

What is the main objective of ICH Q10?

1. To ensure that companies achieve maximum profits

2. To standardize manufacturing methods worldwide

3. To harmonize regulations for safe and effective medicines

4. To oversee marketing strategies in pharmaceuticals

The correct answer is: To harmonize regulations for safe and effective medicines

The main objective of ICH Q10 is to harmonize regulations for safe and effective medicines. ICH Q10, which stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Quality System guideline, focuses on establishing a comprehensive quality management system that enhances pharmaceutical product quality throughout the product lifecycle. This includes design, development, production, and post-market activities. The guideline emphasizes continuous improvement and encourages a risk-based approach to managing quality, which is essential for ensuring that medicines are safe and effective for consumers. By creating a framework that can be adopted by companies globally, ICH Q10 aims to standardize the approach to quality systems, which ultimately supports public health. While the other options touch on important aspects of the pharmaceutical industry, they do not align with the core purpose of ICH Q10. Maximizing profits, standardizing manufacturing methods, or overseeing marketing strategies are not the primary focus of this guideline, which is centered around promoting higher quality and consistency in medicines through a unified regulatory framework.