8. Conclusion

The example presented in this article is in the spirit of the new approach to quality, as defined in the ICH Q8 to ICH Q10 recommendations. Implementing quality by design requires manufacturers to understand the product from conception to marketing, through a deeper understanding of the product and the manufacturing process. The advantages generated by this new approach are undeniably the reduction of the risk of generating a non-compliant product, and the assurance of better quality risk management.

Among the fundamental points of the example we have chosen, we have noted that defining the particle size distribution of the active substance makes it possible to control the impact of this parameter on the initial mixing of the powders, to guarantee the homogeneity of the distribution of the active substance and the expected dissolution characteristics in vitro, and...