| GMP QUALIFIED LABORATORY TESTS UNDER SPANISH, EUROPEAN AND AMERICAN PHARMACOPOEIA |
Quality control on raw materials and finished products:
• Microbiological control:
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- Plate count method
- Detection and determination of pathogenic micro-- organisms
- Bacterial endotoxins (LAL).
- Evaluation of antibiotics
- Sterility testing
- Challenge test |
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| • Physico-chemical control: |
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- Quantification of active ingredients
- Determination of residual solvents
- Determination of ethylene oxide, dioxane residues
- Trace metals
- Determination of fatty acids in raw materials
- Determination of sterols in raw materials
- Capsule and tablet deaggregation test
- Crystalinity
- Injectable particles: subvisible and visible
- Granulometry |
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• Toxicological Control: |
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- Pyrogen tests
- Acute toxicity (DL50)
- Abnormal toxicity (Safety test)
- Local tolerance tests
- Mucous membrane irritation tests (oral, rectal, vaginal…)
- Cytotoxicity |
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| • Medicinal plants control: |
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- Identification by thin layer
- Metals determination
- Determination of ash
- Raw Fiber
- Determination of humidity/dry extract
- Determination of Pesticides
- Determination of Micotoxines
- Determination of residual solvents |
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| • Purified water tests: |
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- Microbiological testing
- Bacterial endotoxins (LAL).
- Physic-chemical control |
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• Testing of surfaces, environments and particles in production rooms
• Validation of analysis methods
• Stability studies under ICH: |
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- Micobiological tests
- Physico-chemical tests
- Photo stability
- Hire of climatic chambers |
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