Proving Your New Design is Production Equivalent

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of Regulatory & Quality Services for EduQuest, offers insight on contract manufacturing and process validation.

Question: I’m dealing with a design contract house on our medical device. They are responsible for all of the documentation needed for design control, etc.

We plan to produce the first 100 units via the contract house. The supplier will do process validation at its location for its respective build. In addition, the final assembly location for production (not the supplier) will perform process validation.

Do you see any issues with this approach?

Answer: Perhaps. The design validation units will have to be either production or production equivalent units. Use this criteria:

  • If the first 100 units are made at the design house with a “frozen” design and a validated process (either a “frozen” production process or one that is nearly complete), and…
  • If the components, raw materials, etc. went through an approved incoming acceptance activity with approved acceptance criteria, and…
  • The units are made with similar equipment and personnel who will build the next 100 or more units…then you can demonstrate the units as production equivalent.

But if the method of manufacture is significantly different than normal production, then the units would NOT be production equivalent. The production differences could include things like different equipment; different levels of personnel experience; different incoming, in-process or finished device acceptance procedures and different methods and criteria.

   
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For example, if the first 100 units are built by the design engineers, those units won’t be equivalent. If the first 100 are built using manual processes (such as manual welding), but future devices will be built using automated processes, the units won’t be equivalent.

You can take the approach that you’ve described but you will need to repeat some—if not most—of the design validation performance and functionality activities once you transfer the design from the design contract house to the regular production facility. 

Process validation only proves that the process can build a device to your design intent and that the process can be kept in a state of control with appropriate monitoring.

So the mere fact that both production processes are validated does not answer the design for manufacturing (or servicing) question, which is answered only with true design validation: Is my device safe and effective, and will it perform and function as described in my initial design input requirements and as my customers need and expect according to my specified design outputs—including my specified method of manufacture? 

When you change the method of manufacturing, you also need to assess the ability of that method to produce a device that is safe and effective. You need to understand whether or not (and how) the manufacturing method could impact your finished design. Does it produce the same design as the other method?

Passing a finished product inspection will not necessarily always answer that question; it will depend on the actual device and its design.

 
Related Resources:

Design Intent: Do I Need to Perform
Verficiation and Validation?

When Do I See a CAPA Specialist?

Pareto Analysis: Tools for New Product Testing

 



Ms. Dion has been with EduQuest since 2002, following 18 years with FDA. Her final eight years with FDA were served at headquarters as the medical device investigator liaison between the Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health, as well as between ORA headquarters and field staff. EduQuest can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

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