Validation and continuous process verification.

  • Supporting life-cycle activities: design, qualification and on-going verification.
  • Deployment of risk analysis tools and methods for process validation. Our consultants act as facilitators and provide RA tools for the multidisciplinary team.
  • Process validation documentation: Validation Master Plan, Process Validation Protocols and Reports. We have experience in oral solid forms, aseptic-sterile, biologics and cellular therapies.
  • Update to new process validation guidances and ANNEX 15 EU GMPs: general procedures,  design, qualification and “on-going verification” protocols and reports.
    • Process state of control assessment and statistical advice.
    • Critical variables to monitor.
    • Exploratory Data Analysis: Data Mining.
    • Statistical Process Control : SPC uni & multivariate.
    • Root cause analysis and troubleshooting.
  • Consulting and advice on “Process Knowledge” deployment.

Cross-contamination in shared facilities.

EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” has changed criteria to assess cross-contamination risks in shared facilities.

Now specific and relevant  toxicological data have to be used to recalculate exposure limits, in order to define if a product can be manufactured in a shared equipment, manufacturing line or even in the same premises than others.

We offer tailored services in this area including:

    • Risk assessment for the introduction of a new API in an existing plant or for the re-evaluation of existing shared premises.
    • Toxicological reports supporting NOAEL and related data as the basis for PDE/ADE calculations. Reports are reviewed and signed by a qualified expert toxicologist.
    • Update the cleaning validation policy with the toxicological criteria.
    • Cleaning validation protocols and reports.
    • Cleaning procedures optimisation: performance and use of water.