Cleaning validation

Within TERANGA Group, ACM Pharma, Cebiphar and UPS Consultants teams combine their analytical & microbiological and regulatory expertise to assist manufacturers through each step of the process:

  • Overview of regulatory framework and requirements (Europe and US)
  • Consulting and assistance for cleaning validation strategy and its implementation
    • Organisation of the Steering Committee
    • Writing of documents (Validation plans, protocols, reports..)
    • Return on investment : optimisation of methods, grouping, worst-case, special products...
    • Which contaminants should be monitored ?
    • How to calculate acceptance thresholds ?
  • Training of managers and operational teams and qualification of sample collecting staff
  • Development and validation of sampling techniques
  • Development, validation and transfer of analytical methods
    • Microbiological analysis
    • Physicochemical analysis : specific (HPLC, GC..) or non-specific methods (TOC..)
  • Sample analyses