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The challenge

ICH Q10 Pharmaceutical Quality System describes the modern quality systems needed to facilitate continuous improvement throughout the life cycle of a medicinal product. The guideline aims to increase the existing requirements for good manufacturing practices (GMP) in the participating regions of ICH (United States, Europe, and Japan) to create modern and robust quality systems. The pharmaceutical quality system included in ICH Q10 aims to achieve several crucial objectives: achieving product realization, establishing and maintaining a state of control, facilitating continuous improvement by identifying and implementing necessary improvements in product quality, process improvements, reduction of variability, innovations, and enhancements to the pharmaceutical quality system, thus increasing the ability to consistently meet quality requirements.

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