Providing Critical Parameters for Your Formulation Design
With Quality by Design (QbD) principles recently adopted by the FDA to advance product and process quality, pharmaceutical manufacturers need to define critical parameters for functionality, outline limits, and ensure these limits meet release specifications.
To better control your production process and final product quality, we have developed the Emprove® program
for a range of products for solid dosage formulation. We provide standardized documentation, facilitate qualification, risk assessment, and process optimization efforts. In addition, we prepare parameters for a wide range of excipients that go beyond the pharmacopeias’ requirements.
A Complete Toolbox to Enhance Your Formulation
The critical parameters include:
- Particle size distribution
- Chemical parameters
- Batch record history on critical parameters
- Elemental impurity information