ICH Q8(R2) guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format (Refer to assignment pre-read #1). The 3.2.P.2 (Pharmaceutical Development) section is intended to provide the Health Authority with a comprehensive understanding of the product and manufacturing process
The “Sakura Bloom Tablets” case study was developed by the ICH working group (Refer to assignment pre-read #2). The Sakura case study is not intended to be a full representation of Module 3 Quality 3.2.P.2 Pharmaceutical Development. Instead, it is a written similar to CTD Module 2.3 (Quality Overall Summary), with only some additional contents corresponding Module 3, 3.2.P.2 Pharmaceutical Development included for context (2.3.P.3 and 2.3.P.5). Remember that CTD Module 2.3 Quality Overall Summary is a summary that follows the scope and the outline of the Body of Data in Module 3. The QOS should not include information, data or justification that was not already included in Module 3 or in other parts of the CTD. The QOS should include sufficient information from each section to provide the Quality reviewer with an overview of Module 3.
FDA has published an illustrative example of a complete Module 3 Quality 3.2.P.2 Pharmaceutical Development, using a Modified Release (MR) Dosage Form product (Refer to assignment pre-read #3). The example illustrates how an applicant should present pharmaceutical development studies and includes additional notes and commentary.
Read the instructions below closely and complete the challenge assignment as follows.
1. 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”
2. 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.
3. Any references should be appropriately cited within your assignment. Late submissions will not be accepted.