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.