Read the instructions below closely and complete the challenge assignment as follows.
- Review the “Sakura Bloom Tablets” Case Study. Compare this case study to the complete Module 3 Quality
3.2.P.2 illustrative example published by FDA.
a. Using both the ICH Q8 requirements and the FDA MR Dosage example as a framework, describe what
sections and associated content are needed to build a comprehensive Module 3 Quality 3.2.P.2 for the “Sakura
Bloom Tablets” - Evaluate the approaches to Design Space that were utilized. Include the following for each case study in the
comparison:
a. Briefly describe the Design Space including critical and other relevant parameters
b. Determine if QRM was applied in the development of the Design Space.
c. Outline the relationship in the Design Space between the inputs (e.g., material attributes and/or process
parameters) and the CQAs, including interactions among the variables.
d. Describe the relationship between the Design Space and other unit operations or process steps
e. Explain how the Design Space was verified as suitable for the commercial process, and any conclusions on
results across different scales
f. Summarize the justification that the control strategy ensures that the manufacturing process is maintained
within the boundaries defined by the Design Space.
Sample Solution
