Veterinarian Pharmaceutical Industry

GMP CERTIFIED LABORATORY
EUROPEAN AND AMERICAN PHARMACOPEA GUIDELINES

Quality controls on raw material and finished product


  • Microbiology controls

- Counts
- Pathogen identification
- Bacterial endotoxins (LAL)
- Antibiotic assessment
- Sterility controls
- Preservative challenge test

  • Physics/chemical controls

- Active principle quantification
- Residual solvent determination
-Ethylene oxide, dioxane, residue determination
- Metal trace determination
- Fatty acid in prime material determination
- Sterols determination in prime material
- Capsule and tablet disruption test
- Crystal structure
- Sub-visible and visible injection particles
- Granulometry

  • Toxicology control

- Pyrogen assay
- Acute toxicity (LD50)
- Safety test
- Local tolerance assays
- Mucose irritation assays (oral, rectal, vaginal,...)
- Cytotoxicity
- REACH assays

  • Medicinal herb control

- Thin layer identification
- Metal determination
- Ash determination
- Raw fibres
- Humidity / dry extract determination
- Pesticide determination
- Myco-toxin determination
- Residual solvent determination

  • Pure and production Waters control

- Microbiology
- Bacterial endotoxins (LAL)
- Physic/Chemicals Control

  • Classed Hall control

- Surfaces
- Environment
- Particles


Validation of analytical methods

 
ICH stability Studies


- Microbiology assays
- Physic/Chemicals assays
- Photo-stability
- Climatic chamber rental

 

Computer assisted image analysis determinations

- Element counting
- Shape, size, surface, density, texture, structure periodicity analyses.
- Automatic classification and recognition of structures from pre-established patterns


Image analysis application development