Medical Devices and Analytical Test Methods

(by Patrick Harris, Business & Technical Project and Product Manager for the Digital Age)

The following case and questions were posed to a PharmaSys employee: "Hi, I am in the middle of writing a validation plan for year 2013. I have a little problem because there is a lot of testing methods/measurement systems inside the factory but  the procedure for validating analytical/test methods is not applicable, and I don't have analytical methods inside the factory because i'm in medical device not pharmaceutical industry. Does FDA clearly divides test methods, analytical methods and measurement systems and requires validation for all of them?  Can anyone comprehensively comment on this topic?"

The FDA Quality System Regulation in 21 CFR 820 are pretty generic in regards to validation requirements for medical device manufacturers.  Design validation (820.30) and Process validation (820.75) are the two main requirements covering validation of medical devices.  Nowhere are test method validation, analytical method validation, or measurement systems validation specifically outlined as requirements.  However, it should be understood that the process validation requirement in 820.75, although vague, has significant impact on the validation requirements.  The FDA expects any part of the manufacturing process to be validated.  This could include analytical/test methods.  Requirement 820.72 states that “[e]ach 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”.  The wording used here is critical; “suitable for its intended purposes” means that the equipment has well-defined specifications and that those specifications have been verified and found to be acceptable (this is validation).  Depending on the piece of equipment and its use, it is possible that calibration may be all that is required to meet the intent of 820.72; but this decision should be documented.

Specifically related to your question, you should assess each of your test methods and measurement systems to determine the level of validation required (if any).  The key will be to document the assessment and your decision to validate (or not validate) in your validation plan.  If something will not be validated, you need to provide a rationale for why it will not be validated (e.g. system will be calibrated only and will be routinely challenged).

Some other resources that may be of use to you would be the FDA guidance on analytical procedures and methods validation (http://www.fda.gov/downloads/Drugs/.../Guidances/ucm122858.pdf) and ICH guidelines on validation of analytical procedures (ICH Q2) at http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.  Although not specifically related to medical devices, you can glean some information on the industry’s stance in relation to these topics from some of these documents.

For more information about PharmaSys, please visit our website at www.pharma-sys.com.