The Quality by Design (QbD) does well in defining the good practices that need to be adhered to in the development of pharmaceutical products. The Quality by Design (QbD) is displayed as a very systematic approach to the development of drugs. It emphasizes on process control and understanding of the processes that define how a product is developed. It is evident that Quality by Design is based on strong scientific ground and a quality manner of managing risks.
The Q8 (R2) demonstrates by example when it defines the QbD approach. The first step in the QbD approach is determining the profile of the product. The quality of the product is defined by identifying the critical quality attributes of the product by trying to relate the raw materials and the arguments involved to perform a risk assessment. Afterward, you develop a design space that helps in laying out the product design in terms of separate components. After that, a control strategy is designed and implemented. Lastly, the product being managed is done so in an iterative manner to ensure that everything is right, and continued improvement is done all the same (Q8 (R2) Pharmaceutical Development).
Quality by Design (QbD) offers a platform where flexible approaches can be provided to meet regional regulatory requirements. Despite being such a versatile tool in the proper design of pharmaceutical products, it is accompanied with various challenges since not all quality issues seem to be solved by this approach (Process Validation: General Principles and Practices).
One of the challenges that accompanies the QbD approach is the lack of clarity of the regulatory expectations. Moreover, the reluctance to share information in the submissions made. For this reason, there is a lack of scientific justification for the control strategy specified. Lastly, the control procedure is not well defined when it comes to the evolution of the product’s life cycle.
In conclusion, QbD offers an enhanced understanding of the product being designed. Moreover, it facilitates a higher process capability and increased flexibility to implement changes. Lastly, the value is highly considered in QbD.
Works Cited
Process Validation: General Principles and Practices. 2nd Ed. New Hampshire Ave: Rockville Pike, 2016. Web. 26 Mar. 2016.
Q8 (R2) Pharmaceutical Development. 4th Ed. New Hampshire Ave.: Silver Spring, 2016. Web. 26 Mar. 2016.
