Certified Pharmaceutical GMP Professional Practice

What is the primary objective of ICH Q10?

1. To achieve product realization

2. To establish international regulatory guidelines

3. To reduce production costs

4. To enhance employee training

The correct answer is: To achieve product realization

The primary objective of ICH Q10 is to achieve product realization. This guideline, developed by the International Council for Harmonisation (ICH), focuses on creating a robust pharmaceutical quality system that spans the entire lifecycle of a product, from development through to post-market activities. The emphasis on product realization ensures that products not only meet established quality specifications but also effectively fulfill patient needs and regulatory requirements. The guideline encourages organizations to adopt a quality-by-design approach, which integrates quality measures into every stage of the product lifecycle. As a result, the overarching goal is to deliver high-quality medicines that are safe and effective for consumers. By concentrating on product realization, ICH Q10 helps companies define and implement controls necessary to maintain product quality throughout its lifecycle. While the other options, such as establishing international regulatory guidelines or enhancing employee training, contribute to the broader context of pharmaceutical quality and compliance, they do not encapsulate the central aim of ICH Q10 in the same way that achieving product realization does.