ServiceProject

GxP Audits and Third Party Auditing Services

  • Quality System Auditing
  • Equipment and Facility Auditing (GEP)
  • IT Quality System Audits
  • Software Quality Audits
  • GMP Audits
  • GCP Audits (CRO & Clinical Site Audits)
  • Laboratory System and GLP Audits
  • Due diligence Audit
  • Laboratory data integrity audits
  • For cause audits
  • CMO selection Auditing
  • Product and process development audits
  • Capital investment projects audits
  • Contract Vendor & Supplier Audits
    1. API

    2. Intermediates (incl. Solvent, Process GAS, etc.)

    3. Excipients (incl. basic chemicals, cosmetic ingredients, disposables, etc.)

    4. Finished Product (solid, semi-solid, liquid, sterile, etc.)

    5. Packaging materials (Primary/secondary/Tertiary)

    6. Artworks and Printing Suppliers

    7. Warehouse, Storage, “Picking” and Distribution

    8. Brokers, Agents, Distributors

    9. Transport and Cold chain

    10. Contract External Testing Laboratories

    11. Contract services (Sterilization, Packaging, Calibration, Pest control, Maintenance, Labelling, etc.)

    12. Contract Manufacturers

    13. Clinical Materials & their Distribution