Qualité et audits

AUDITS

With our partner

  • Audits of API suppliers and pharmaceutical excipients
  • Distributor audits
  • Audits of pharmaceutical sub-contractors
  • Suppliers of raw materials
    • validation of the Quality Control system
    • audit of quality systems
  • Shared Audits
  • Audit of suppliers of cosmetic excipients
  • Evaluation of cosmetic GMP processes

QUALITY EVALUATION

With our partner

  • Process quality
    • risk analysis for the management of suppliers and subcontractors
    • optimization of processes and product flows
    • harmonization of multi-site practices
    • qualification of the equipment: from the elaboration of the protocol to the writing of the qualification report
    • setting up Lean management

  • Medical devices
    • Support for the implementation of the quality system according to ISO 13485 standard
    • Preparation of the certification audit by the notified body and inspections by competent authorities

QUALIFICATION & VALIDATION

With our partner

  • Policy development and validation strategy
  • Design and realization of criticality analyzes
  • Document Architecture and Validation
  • Writing of all validation documents
  • Supervision of tests, management of nonconformities