GXPs - what do authorities expect

Good practice principles are established in many disciplines of the pharma business. Initial implementation, continuous maintenance and updating require constant effort but pay back by improved quality of work and products as well as international acceptance by authorities.
  • GMP: Good Manufacturing Practice for APIs and formulation
  • GLP: Good Laboratory Practice for preclinical development and special analytics
  • GCP: Good Clinical Practice for all Phases of clinical research and development from Phase 0 to Phase IV
  • ICH: Guidelines for Quality, Safety, Efficacy of pharma products and the corresponding activities
We provide:
  • Development Quality management systems (including SOPs, templates, etc.)
  • Auditing and preparation of inspections
  • Quality Assurance concepts
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actual version 27.02.2018