Quality Assurance and Quality Control

cGMP Quality Control Testing/analytical quality control laboratories fully equipped to conduct test programs for pharmaceutical clients, according to the pharmacopoeia (e.g. EP,SUP,BP and JP) and to in-house specifications for raw materials (excipients and active pharmaceuticals ingredients), finished

Products and intermediate products, packaging materials, purified and tap water.

We offer a wide range of analytical techniques, including the following key techniques

Chromatography

  • TLC
  • HPLC/UPLC (with UV,PDA, RI Detectors)
  • GC/HS (with FID Detectors)

Spectroscopy

  • UV/Vis
  • IR, FTIR
  • Atomic absorption spectroscopy – flame/graphite/VGA
  • MALDI TOF mass spectrometry for microbial identification
  • TOC (Total Organic Carbon) analysis

Chemical, Physical and physiochemical testing services

  • Assay and Purity (e.g. Chromatography, Titration, Limit Tests)
  • Identity (e.g. Spectroscopy, Chromatography)
  • Dissolution Test (On  Line/Off Line)
  • Pharmaceutical Water Analysis (e.g. TOC)
  • Water Content (Loss on Drying,
  • Disintegration, Friability
  • Appearance (e.g. Clarity, Opalescene)
  • pH and Conductivity
  • Uniform of Mass etc.

Microbiology testing:

 Microbial Limits Tests

  • Microbial Contaminant Identification
  • Preservatives Testing And Microbial Challenges
  • Bacterial Endotoxins
  • Environmental Monitoring
  • Water Systems Validation
  • Production Facility Qualification
  • Cleaning Validation

Pharmaceutical Quality Assurance

Business consulting in the process of establishing the system of quality management according to national and international standards (ISO 9001, ISO 14001, ISO 18001, cGMP)

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