Products for Design Validation - FDA Requirements



Hello all,
I have a question re design validation. FDA requires that during design validation, product used for the validation should be the "initial production units, lots, or batches, or their equivalents". we manufacture Titanium Implants, and our process usually starts in CNC department to machine the parts, and then there are several surface treatments. my question is, can we machine the parts in R&D workshop, then inspect and release them by QA and then continue the surface treatment in production. Meaning, could those parts meet the term of "their equivalent" quoted before? The rational here is that the machining step of the production process, is mainly about meeting the drawing requirements, and it does not really matter if we met them by using R&D machines or production machines. This can really reduce our time to market, but we have to be in compliance?
thanks you for your attention!

Mark Meer

Trusted Information Resource
This is one of those cases where there are no hard-and-fast rules. The bottom-line is that you should be confident that what you are validating can be reasonably argued to be "equivalent" to production units (with as much backing evidence as you deem necessary).

Here's what I suggest:
  1. Make sure you've maintained sufficiently detailed records of the units being tested, so you can identify any differences between the tested units and (future) production units.
  2. Look at your validation protocol and assess: do the differences (e.g. surface treatment) actually have any impact on the results?
  3. Justify and document this decision.

It's generally understood that prototype units are not always identical to production units. The key is to justify whether or not these differences actually impact the results of tests...



I would completely agree with Mark comments on the documentation of prototype and production builds. Adding to that, the team needs to make sure the R&D product machine is qualified and validated. This might be calibration, PM's, etc that tells us that the product has been handled in right way before use and surface treatment process is validated i.e. raw materials used could be traceable on the incoming/receiving inspection plans.

This might be definitely helpful for the audit.
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