Pharmaceutical Industry

GMP QUALIFIED LABORATORY TESTS UNDER SPANISH, EUROPEAN AND AMERICAN PHARMACOPOEIA

Quality control on raw materials and finished products:

  • Microbiological control:
  • Plate count method
  • Detection and determination of pathogenic micro-- organisms
  • Bacterial endotoxins (LAL)
  • Evaluation of antibiotics
  • Sterility testing
  • Challenge test

Physico-chemical control:

  • 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

Toxicological Control:

  • Pyrogen tests
  • Acute toxicity (DL50)
  • Abnormal toxicity (Safety test)
  • Local tolerance tests
  • Mucous membrane irritation tests (oral, rectal, vaginal…)

Medicinal plants control:

  • 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

Purified water tests:

  • Microbiological testing
  • Bacterial endotoxins (LAL)
  • Physic-chemical control

Validation of analysis methods / Stability studies under ICH:

  • Micobiological tests
  • Physico-chemical tests
  • Photo stability
  • Hire of climatic chambers