At Munit, we apply the Quality by Design (QbD) approach to ensure a robust, science-based strategy in API micronization. From process design to validation, we integrate risk assessment, DOE, and critical quality attributes (CQAs) to optimize outcomes.
Why QbD Matters in API Micronization
QbD enables better understanding and control over the variables that influence your API’s particle size, uniformity, stability, and performance — helping reduce variability, ensure compliance, and speed up development timelines.
Our QbD Implementation Strategy
We support clients by:
- Defining CQAs and CPPs (critical process parameters)
- Performing Design of Experiments (DOE) studies
- Establishing a control strategy
- Documenting process knowledge for regulatory submission
Our QbD workflows align with ICH Q8–Q11 guidelines and are scalable across R&D to commercial.
Full GMP Integration
Our QbD processes are executed in GMP-certified environments with complete documentation, including validation reports, protocol templates, and change management procedures.
Build quality into your process from the start.
Work with Munit to implement QbD in API development.