List of DHF requirements

List of DHF requirements

Which are the DHF requirements that the FDA looks for?

DHF requirements are a very important part of the DHF. The DHF shows conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001.

It is meant to show that the inputs that were specified for a product were met by the resulting product, and also how it got there under conditions of control, once a start date has been established. DHF requirements prove the efficacy and effectiveness of design control elements.

Details

These are the parameters or elements of the DHF requirements that need to be fulfilled:

  • Design planning –should relate the design and development plan –could ideally have Gantt Charts, reflecting changes whenever they are made
  • Design input –could explain requirements, Initial Product Performance specifications (marketing and engineering), and could include applicable standards, such as ISO or whichever
  • Design output: should consist of systems to evaluate design input requirements and should cover verification/inspection; QC and ensure proper functioning
  • Design changes –the FDA recognizes that any kind of change runs the risk of degrading the product; hence, the manufacturer should be on the lookout for possible snags
  • Design review(s), including by an independent reviewer, one who does not have a stake in the review process, should be prior to production. Should serve as milestones to take the product to the next level
  • Design verification/validation –the same as testing or inspection. It is basically meant to demonstrate that design output was a product of design input
  • Design transfer –involves transferring the R and D documents to design documents
  • Design history file, a complete documentation to demonstrate all of the above. This is the end result of all your design activities, proving that you got the process right.

 

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