Aniket Chaudhari
Normally US FDA audit happens after five years from preparation of design history file for startups, it is two years for running medical devices and for Class II and III with reported adverse event, it can be at any time.
Considering recent Pandemic of corona FDA also will start using hybrid audit system which means onsite for examining certain physical things and offsite review of documentation. This means one must be ready all the time.
If FDA audit does not go well, it can have serious consequences on business.
DHF is heart of product. In short this involves design control process and its documentation.
The FDA inspector will request a copy of the company’s design controls procedure and be looking for the following elements, as defined in 21 CFR 820.30:
· Design and development planning.
· Design input.
· Design output.
· Design review.
· Design verification.
· Design validation, with software validation if applicable.
· Design transfer.
· Design changes.
· and DHF document which comprises all above documents.
One can have paper based DHF or electronic both are valid but paper-based system may require lot of manual control and proper traceability for producing them quickly during inspection. This way electronic system helps trace faster and more organized manner.
With proper preparation and a robust electronic system, FDA audits becomes easier, time saving and non-intimidating.
Design control documentation involves all the elements described above and individual document of each element.
While doing inspection inspector may select one of the samples of any DHF but not knowing which one, all DHF records with approved changes should be updated all the time because they are referred throughout the lifecycle of product.
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Aniket Chaudhari
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