GMP – Good Manufacturing Practice

GMP sterilproduktionGxP Pharma Support A/S provides professional quality support within several GMP aspects. The company has 13 years of experience from international production in the pharmaceutical industry, and 7 years of regulatory experience from The Danish Health and Medicines Authority and EMA.

Several hundred inspections in Denmark and worldwide have been performed.

GxP-Pharma Support A/S also exercises project management within several fields of GMP.

The professional expertise covers the following GMP production areas:

  • GMP kapslerAPI production
  • Animal sourced products
  • Aseptic production / sterile production
  • Biotech production; up-stream and down-steam processes, re-combinant products, master cell banks and working cell banks, monoclonal antibodies etc.
  • Clinical trials in small scale GMP company
  • Cytostatika
  • Packaging
  • Production of excipients
  • Production of liquid medicines; liquids, creams, aerosols etc.
  • Production of solid dosage forms; powder, tablets and capsules
  • Quality Assurance
  • Quality Control
  • Utilities (water systems, HVAC, compressed air)
  • Vaccine production incl. biosafety facilities and associated animal sheds
  • Warehousing

 

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