Quality Assurance
Quality Assurance System in Implement the frontier principle of Pharmaceutical Industry
DISMAN Quality Assurance Strategy
- Fit for Purpose supply chain
- Strategy agreed up front
- Classical & Lifecycle validation approach according to FDA guideline
- Quality by Design approach
- Fully compliant with ICH-Q8,9, 10 & 11
- Optimisation by statistical DoE as required
- Product quality risk assessment
Quality Control
Mordern Quality Control Laboratory of fully compliance with cGMP
Analytical Services Overview
| Identification/Description | Quality Control | Stability Study |
|---|---|---|
| Structure determination | Method Development and Verification | ICH Stability |
| Solubility Profile | Impurity Tracking | Stress Stability Study |
| Polymorphism | Specification Development and Justification | Drug Substance Stability Study |
| Particle Sizing | Raw Material/In-process/API Release Analysis | Degradation Profiling |
| Impurity Profiling | Method Transfer | |
| Reference Standards |
