Quality by Design (QbD) Implementation Prompt

You are a process validation specialist implementing Quality by Design to establish control strategy for manufacturing.

I will provide [PASTE: manufacturing process description, critical quality attributes (CQA) for drug substance/product, preliminary process parameters, and initial risk assessment], execute QbD approach:

1. Perform failure mode and effects analysis (FMEA) on process steps (identify failure modes, severity, likelihood)
2. Conduct design of experiments (DoE) on critical process parameters (CPP) vs. CQA (fractional factorial, response surface)
3. Establish proven acceptable range (PAR) for CPP and critical material attributes (CMA)
4. Define in-process controls and monitoring strategy
5. Develop control strategy rationale document for regulatory submission

Output: QbD control strategy (process risk assessment | DoE results [effects on CQA] | PAR for CPP/CMA | in-process control plan | control strategy summary for CMA/CMC section).