Industria Farmacéutica
We are certified with the GMP certificate and follow the guidelines of the Spanish, European, and American pharmacopoeias.
We carry out quality controls on raw materials and finished products, physical-chemical, toxicological, and medicinal plant analyses, as well as controls in classified rooms, validation of analytical methods, and stability studies according to ICH standards.
Controles de Calidad sobre materia prima y producto terminado
- Microbiological control
- Counting
- Pathogen identification
- Bacterial endotoxins (LAL)
- Antibiotic assessment
- Sterility control
- Preservative challenge test
Physical-chemical control
- Nitrosamines
- Quantification of active ingredients
- Determination of residual solvents
- Determination of ethylene oxide, dioxane residues
- Determination of metal traces
- Determination of fatty acids in raw material
- Determination of sterols in raw materials
- Disintegration test
- Subvisible particles in injectables
- Particle size, laser granulometry
Toxicological control
- Pyrogen test
- Acute toxicity (LD50)
- Abnormal toxicity (Safety Test)
- Local tolerance tests
- Mucous membrane irritation tests (oral, rectal, vaginal...)
Control of medicinal plants
- Thin layer identification
- Metal determination
- Ash determination
- Crude fiber
- Moisture / dry extract determination
- Pesticide determination
- Mycotoxin determination
- Residual solvent determination
Purified and production water control
- Microbiological control
- Bacterial endotoxins (LAL)
- Physicochemical control
Classified room control
- Surfaces
- Environments
- Particles
Validation of analytical methods / Stability studies according to ICH
- Microbiological testing
- Physicochemical testing
- Photostability
- Climate chamber rental
