We have two distinct GMP validation departments; chemistry and microbiology. Each validation department is dedicated to development, validation, verification, recovery and inter-laboratory transfer of analytical methods. Typical samples include raw materials, Active Pharmaceutical Ingredients (API), finished products, cleaning and environmental samples.
Methods are validated according to current ICH Q2 guidances and client’s requirements for:
- Determining the dosage of active ingredients and finished products
- Degradation studies for the development of stability indicating methods
- Dissolution studies for all types of solid dosage forms
- Quantification and qualification of residual solvents and impurities/related substances
- Cleaning methods validation: research and quantification of washing reagents and recovery on SS plates and other materials
We perform technological transfers of existing methods from other laboratories and also provide verifications of Pharmacopeias.
We comply with all compendial requirements. In conjunction with our parent and affiliate Neopharm, we develop and validate microbiology methods for:
- Total Aerobic Microbial Counts
- Total Yeast & Molds Counts
- Pathogen Detection
- Antimicrobial Effectiveness Testing
- Bacterial Endotoxins