Validation of Cleaning Equipment Manufacturing – Dry Forms

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Validation of Cleaning Equipment Manufacturing - Dry Forms

Pharmaceutical industry


Études de cas CaduceumAchievements

  • URS in order to consult suppliers
  • Cleaning validation plan with the development of the validation strategy
  • Toxicological evaluation with PDE determination (50 molecules)
  • Development of acceptance criteria
  • Realization of a gap analysis with definition of an action plan to meet the regulatory requirements in force
  • Harmonization of manual cleaning processes
  • Update of cleaning procedures
  • Training of staff to validate cleaning

 

 

Norms  GMP Annex 15
Key Skills Cleaning Validation Toxicology
Type of Commitment Day to Day Basis
CaduCeum Team  3 consultants

Management by 1 SME

Duration 4 months