Medical device manufacturers are always interested in knowing what FDA's next area of focus will be. Well, if you're an In Vitro Diagnostic manufacturer you might review your measurement systems. Medical device manufacturers know that their production processes need to be validated. Process validation, as you know, depends on a foundation of measurement. The testing of raw materials, intermediate products, final products, and the measurements of process parameters during production must all conform to the Medical Device Good Manufacturing Process regulation, 21 CFR 820. The regulation says that for receiving, in-process, and finished device acceptance "Each manufacturer shall establish and maintain procedures for ... inspections, tests, or other verification activities." The regulation further states in "Sec. 820.72 Inspection, measuring, and test equipment. (a)...Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results." This section of the regulation has a lot of implications. One of which is that all of your instrumentation has to be properly calibrated. Any standards that are used to calibrate the instruments need to be traceable to a nationally or internationally recognized organization like the National Institute of Standards and Technology, NIST. For instance, any scale that is used in your manufacturing process must be calibrated relative to a NIST traceable weight. You must keep a record in your files that proves that your standard weight is traceable to NIST. Simple calibration is usually adequate for instruments that directly measure physical or chemical characteristics. An example of a direct physical measurement would be a temperature measurement with a simple device, like a thermometer or a thermocouple. A pH meter would be an example of a direct chemical measurement. However, if a more complicated measurement is done, then you must validate the method. What do I mean by this statement? Some measurements cannot be made directly. They may involve a separation process wherein the analyte needs to be isolated before that physical or chemical measurement can be made. This happens if you are using a more complex method, like an HPLC or an enzyme assay. These methods must be validated through a process called Analytical Method Validation (AMV). In a moment we will briefly review the components of AMV. But first let's discuss the purpose of AMV. The answer, of course, is to make sure that the analytical method itself is a high quality operation. In other words, we want to prove that the method is accurate, precise, and otherwise capable of telling us what we need to know about the analyte. And how do we find out whether our measurement system is accurate, precise, and otherwise capable? We measure it. Unless we have measured the measurement system we have no knowledge whatever that the numbers it generates are any good at all. Any money spent running manufacturing processes with unvalidated analytical methods is wasted. In fact, it's worse than wasted because it makes us think we have a reliable number when the reality is that we know nothing. If we didn't run any test at all, at least we'd know that we know nothing. There are eleven main components that need to be considered for an analytical method validation protocol. These factors are to be applied to each and every laboratory test that is critical to the IVD manufacturing process, as well as the stability program, and any process validation. Not all of the eleven factors may apply to each type of testing that is performed. However, a thorough review must be done in order to ensure a complete protocol has been written. The factors are Specificity, Linearity, Accuracy, Precision, Robustness, Range, Detection Limit (LOD), Quantitation Limit (LOQ), Ruggedness, Selectivity,and System Suitability. When you validate your analytical methods, you assure that the numbers that you generate are believable – believable by you, so that you can make good business decisions, but also by the FDA when they inspect your facility. In conclusion, if you are an IVD manufacturer you should review the measurement systems that are critical to your manufacturing process. If any of those measurements are not simple, direct physical/chemical methods, they need to be validated.
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Medical device manufacturers are always interested in knowing what FDA's next area of focus will be. Well, if you're an In Vitro Diagnostic manufacturer you might review your measurement systems.
Norm Howe is a Sr. Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a PhD in chemistry at UCLA. He is an adjunct professor of Regulatory Science at the University of Michigan, Ann Arbor. For more information about GMP training see http://www.vcillc.com
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