GXP Audits


GMP/GDP, GLP, GCP audit activities

 

Active Pharmaceutical Ingreedients (GMP)

  • - Classical Fermentation
  • - Chemical Synthesis
  • - Biological and Biotechnology processes including Cell Banking

Excipients (GMP)

  • - Organic solvents
  • - Inorganic salts, gasses, liquids and solids

Packaging materials (GMP)

  • - Vials, ampules, syringes, stoppers, seals
  • - Tubes, plastic bottles, foils
  • - Labels, cartons, leaflets

Pharmaceutical Products (GMP/GDP)
Investigational Medicinal Products (Phase I-II-III)

  • - Sterile and aseptic products, lyophilised products
  • - Sterilisation processes
  • - Tablets, mixtures, soft gels
  • - Ointments and creams

Contractors (GXP)

  • - Contract Manufacture Organisations (GMP)
  • - Contract Laboratories (GMP)
  • - Contract Research Organisations:
    • Toxicology studies (GLP)
    • Clinical Trials (GCP)
    • Central Laboratories (GCP/GLP)


Mock Inspection (GMP)

 

Target Groups:

Small and Mid Cap Companies (Pharma and Biotech)