_qualitaetssicherung

QS – GMP

Areas of work:

  • SMF
  • Identification number system
  • Management and filing of documents
  • Audits
  • Self-inspections
  • Training
  • Risk management
  • Certification
  • Validation
  • Deviation management
  • Change management
  • Corrective and preventative actions (CAPA)
  • Trend analyses
  • Complaints and returns processing
  • Supply chain management
    • Supplier selection, approval and certification; contract manufacturers, contract laboratories, suppliers of output substances (API, auxiliary material, packaging), suppliers of additional materials (consumable supplies), external suppliers
    • Audits
    • Contractual matters: technical agreement, quality assurance agreement