Commissioning and Validation

    Working in a highly regulated market sector in demanding industries means WHP is aware of Current Good Manufacturing Practice (cGMP), Medicines and Healthcare Products Regulatory Agency (MHRA) and Food and Drug Administration (FDA) compliance requirements where validation and quality assurance are essential factors of best practice.

    Commissioning and validation requires more than just an understanding of the mechanical and build components of hygienic, sterile processing environments and manufacturing facilities – it requires a structured approach from design and build to delivery, installation, commissioning and planned maintenance.

    WHP’s approach flows throughout the entire project from initial design to handover.

    WHP uses a four-stage commissioning and validation approach.

    Validation Master Plan:

    • Maintained throughout the entire project lifecycle
    • Identifies scope, objectives, roles and responsibilities

    Impact Assessment:

    • Review qualification requirements with client
    • Ensure commissioning and validation efforts are focussed
    • Enable the design process to include qualification requirements

    Validation Controls:

    • Procedural controls agreed by WHP and client
    • Documentation to be capable of integration with existing commissioning and validation procedures

    Validation Execution:

    • Project approach including progress reporting
    • Integration of vendor testing and commissioning data
    • Reduced duration and increased efficiency

    At WHP nothing is left to chance: at every stage we ensure efficacy.