What should you do first if you are a manufacturer preparing for an FDA inspection? First of all, you must have a good understanding of how the FDA works. It includes FDA verification processes and systems.
You may browse the web to know more about US FDA assessment 483.
The FDA provides appropriate training materials, guides, and manuals to help you understand your requirements and processes. In this article, we will cover the educational and training materials you will need to successfully pass an FDA exam or audit.
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How do FDA audits work?
As a first step towards product approval, you need to know how the FDA is reviewed, what specific requirements it has, and how they go through the review process. It is important for beginners to know the documentation process.
When an FDA employee visits the site, the first document issued to site administrators is form "FDA 482", which is the inspection notification and is the agency's first official document.
In order to better prepare for an inspection, you must first understand the purpose of the inspection or audit. Regulators want to ensure that manufacturers fully adhere to Good Manufacturing Practices and Hygiene Concepts.
Obviously, the authorities want to ensure that the final product has the necessary purity, quality and special identity associated with it.
The purpose of inspection is also to identify practices that may result in illegalities in the manufacture and distribution of products. Therefore, it is up to FDA staff to ensure that official fees are fully met.