Q: We are currently re-writing our design control procedure and keep reaching a sticking point regarding the order of occurrence of design validation, design transfer and process validation.
It’s my understanding that process validation should occur after design validation and design transfer. Is this correct?
A: In many important ways, the steps overlap. Design transfer should start early in the design process. Manufacturability is a key part of design. Before you build design validation units, you must have a completed design and approved manufacturing procedures, although they may still be in red-line form.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Your processes need to be fully characterized, using the same equipment and procedures you think will be used for the commercial product.[/pullquote]
In addition, your processes need to be fully characterized, using the same equipment and procedures you think will be used for the commercial product. You should have everything properly installed and operationally qualified, at a minimum.
Your process risk assessments also should be complete. These assessments should include packaging and labeling operations; all manufacturing processes for components, sub-assemblies and final assemblies; and any further processing steps such as sterilization, lyophilization, etc. Design transfer is not complete until all your processes have been validated.
Finally, after your validations are complete, you need to assess the manufacturing and design documents used to build your design validation units against those that will be used to produce commercial product. You need to make sure that the units used for design validation were production or at least production-equivalent units.
Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services, 18 years as an FDA investigator and co-developer of FDA’s Quality Systems Inspection Technique (QSIT), and lead instructor of EduQuest’s Design Control for Medical Devices training class.