GMP – Good Manufacturing Practice
GxP 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:
- API 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
- 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