One of the most important phases of a medical product development life cycle is the relationship between your company’s validation expert and the original equipment manufacturer (OEM) of your medical product.
It is the test run for approval and commercialization. The importance of the transition from validation process to manufacturing will determine FDA approval, the timing of delivery to market, keeping costs within budgeted estimates, and the success of your product.
As a contract manufacturer, at BMP Medical, more than just building medical devices, we build relationships with medical device inventors and innovators. We will work with your validation expert to ensure that validation processes through manufacturing are consistently met to produce devices that meet your company’s specifications as well as being awarded FDA approval.
The FDA requires that validation must provide objective evidence and confirmation through examination that user needs and intended uses as stated are fulfilled. In that regard, as your contract manufacturer, we work with your validation expert hand-in-hand to fulfill this requirement by following standard industry protocols. He or she will have complete knowledge of our OEM medical processes and equipment which makes for an easy transition to manufacturing.
The IQ Protocol
The early stage of process validation, i.e., the installation qualification (IQ) protocol, is critical. Validation methods and criteria are established for your medical device, and also to identify and assess the performance characteristics. For example, this is when we verify that the equipment is correctly installed, any or all instruments are calibrated as needed, and the necessary power supply is met.
The OQ Protocol
The next stage of the process validation, i.e., the operational qualification (OQ) protocol, is to focus on the product risk analysis. OQ is intended to identify and greatly lessen the risk of process failure in large part through statistical modeling, mapping systems and analysis of data collected during the IQ stage.
The PQ Protocol
The next stage of process validation is to perform a number of test runs to verify that your system is operating as expected. The performance qualification (PQ) protocol should be viewed as a pilot production phase that should simulate as much as possible the actual manufacturing conditions of your medical device. The PQ should simulate real-world conditions. Typical tests are up to three production runs (or more if necessary). Statistical modeling can be used to determine the desired yield of the production runs.
Other Areas of Process Validation Consideration
Process validation should consider other real-world conditions such as product packaging and labeling. The ability to anticipate unexpected consequences in packaging design could affect the performance of your product. A prototype delivered or carried in a custom-made case for demonstration is most likely not made of the same components as the packaging material. It is not too uncommon for electrostatic discharge (ESD) failures in electronic medical devices to occur because of packaging material, which is why such packaging should be part of the validation process.
Process validation should also anticipate real-world environmental conditions. Depending on your medical device, simulated temperature fluctuations, humidity levels, shock and vibration stress, or corrosive atmospheres, etc., should be part of the process validation. Unexpected environmental encounters during shipment, handling, and installation most likely will exceed unexpected encounters during actual use. It is best that the validation expert address this issue during the process validation in conjunction with the OEM.
In its decision-making, the FDA relies not only on sound, objective science by medical device inventors and innovators, but a solid foundation for their product development and manufacturing. Process validation is not just an important step, but required by the FDA to receive approval of your medical device. Our role in process validation at BMP Medical is to provide medical device inventors and innovators with the necessary tools to measure the product’s performance with efficiency and accuracy, and to adhere to protocols at all points in the process to ensure an easy transition for FDA approval and the successful commercialization of your device.