Process Validation Activities for Medical Devices

     

Process Validation for Medical Devices is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device.



IZiel works with your team to assist you to complete all the following Process Validation for Medical Devices activities

  • Process Validation Master Plan (PVMP)
    • Define the manufacturing process flow.
    • For each process step, define the process requirements.
  • Process Characterization
    • Process Characterization is the science of understanding the effects of inputs and other uncontrollable variables on the desired outputs or requirements of a process using robust and proven statistical methodologies.
    • Process Characterization is the first step of the Operational Qualification (OQ) activity.
  • Equipment Installation and Qualification (IQ)
    • IQ is the task of proving that the equipment is fit for its intended use.
    • Requirements for the equipment considering its use and functionality are carefully captured.
    • Within a lifecycle approach to process validation, employing a risk-based decision making throughout that lifecycle, helps identify critical process parameters throughout the lifecycle as opposed to only certain stages of the process

  • Operational Qualification (OQ) –  
    • Operational Qualification involves using the results of the Process Characterization studies and determining a well optimized process window.
    • IZiel will work with the process experts to conduct Process Characterization and Process Optimization using advanced statistical tools like Designed Experimentation and Response Surface Modelling.
  • Performance Qualification (PQ)
    • To ensure that part to part or lot to lot variation does not impact the outputs of the process, a Performance Qualification (PQ) run is done. 5 lot of input materials or parts are taken, and the process nominal setting is challenged with this normally expected lot to lot variations.
    • A high process capability is expected out of PQ run data since this represents long term process capability and stability.
  • Test Method Development (TMD) & Validation (TMV)
    • IZiel can provide support in the development and validation of Test Methods for inspections for both receiving and during in-process manufacturing.
    • With a strong statistical background of its team, smooth executing of TMV’s can be achieved.

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