Manufacturers need to have their design history file available for a FDA inspection. This should demonstrate that the DHF meets all the requirements of the FDA regulations.

What to avoid in your DHF?

Disorganized File

Organize all the files and make it presentable for the inspection will help a lot. Having a disorganized file will be difficult when finding information, that will give the FDA an impression of uncomplete document.

Disorganized Paper

This is also something to deal with disorganization. You should have all the paper documents organized, in the right order and need to avoid missing important parts as signatures. Information on the DHF need always to be exact and updated.

Overcomplicated DHF

Do not create unnecessary works. Make it simple but complete and easy to understand.

Do not add everything you can. All you have to do is to demonstrate that your company is following the requirements given by the FDA. You don’t need to include business-related items, just include information related to safety and efficacy asked by the FDA. The DHF should consider on the design control activities.

No Traceability Matrices

It is important to show the FDA all the steps of your DHF making and show the relationship from design control activities. This is one of the most important thing to prepare for the inspection.

Traceability Matrix made on the last minute before inspection

Prepare the traceability matrix during the development. This will help to point out what are going to happen, have a prevision and then avoid delay or any other mistakes.

Do not update documents

The DHF need to be accurate, so you need to keep it update in every phase of the development. The FDA believe that all the changes will be arbitrated from the design control perspective as all the changes must be verified before the production.

DHF and design control will be both inspected by the FDA, again, don’t wait till the last minute to complete them.

Having all the above points completed, your documents organized, updated and containing evidences of your products meeting the requirements of safety and efficacy, you won’t have any problem when the FDA inspection. Otherwise, if you have your files incomplete, disorganized and doesn’t show evidences, then you probably get an order of not to sell until your DHF is complete and presentable.