Cleaning Validation - PDE Intergration

Detailed experience in the developent of complete cleaning validation plan & tools for adaptation within the new regulataroy environment, factoring in all aspects of the EMA Guidelines of Setting Health Based Exposure Limits:

  • Resourced research into the creation of PDE certification for cleaning validation
  • Resourced research into the creation of a PDE MACO mathamatical model
  • Developed PDE based cleaning verification/validation risk assessment tool
  • Developed PDE MACO calucator for cleaning verificaiton/validation operations
  • PDE cleaning validation master plan review including production MACO matrix
  • Cleaning Validation Regime Setup & Support

    We at MCP have dedicated resources for the setup, testing and implementation of a cleaning verification and validation regime within the GxP enviroment along with expertise in providing support for new cleaning requirements - new products or equipment that are to be brought onsite.

    75

    CV: Projects Completed

    122

    CV: Product Changover Assessed/Updated Per Run

    12

    PDE Certifications Approved

    31

    Equipment Validation Deadlines Achieved