Cosmetics

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Our cosmetics services


  • Cosmetovigilance studies
  • Product risk management
  • Evaluation tests ( effectiveness, performance)
  • Formulation ( optimization and research of new formulas)
  • Analytical transfers
  • Project management
    • Budget, planning
    • URS (user requirement specification ) redaction
    • Risk analysis process
    • Supplier management
    • Design qualification/ choice of suppliers
    • Commissioning
    • Revamping
    • Scale-up
  • Continuous improvement
  • Maintenance and metrology

NORMATIVE ENVIRONMENT

  • GMP
  • GLP

Quality management

  • Gap analysis
  • Alignment and standardization of procedures
  • Document management ( instructions, procedures, operating procedures …)
  • Staff training Management
  • Preparation of inspections/audits (notified bodies, suppliers, FDA…)

Operational quality assurance

  • Corrective actions and Preventive Actions ( CAPA), abnormalities and deviations management
  • Change control management
  • Customer complaint management
  • Environmental follow-up
  • Supplier quality

Qualification/ validation

  • FAT/SAT/QI/QO/QP ( controlled atmosphere form class A to D)
  • Cleaning Validation ( manual, semi-automatic and CIP ( cleaning-in-place) )
  • Process validation ( SIP ( sterilization in-place), Formulation, Distribution , visual inspection, Packaging)
  • CSV/ ASV ( ERP, Excel sheets, software, automates )

Quality Control

  • Laboratory analysis (HPLC, NMR, IR…)
  • Validation of analytical methods

NORMATIVE ENVIRONMENT

  • ISO 22716
  • GMP, GLP
  • 21 CFR PART 11
  • Writing of the product’s notice
    • Preparation of the file
    • Writing of the report of the safety evaluation
  •  File update according the evolution of régulations and the product life cycle (Raw materials, process…)
  • Regulatory monitoring
  • Supervision of labeling information

NORMATIVE ENVIRONMENT

  • ISO 22716
  • ANSM
  • FDA