FDA Method Validation Guidelines

The FDA validation process is designed to make sure a product has been produced according to its specifications and fulfills its intended purpose. It is a quality control system that makes sure a product is of high quality. There are a couple of guidelines on what the process should look like.

Validation Plan

• First, a validation plan should be outlined. It should contain the exact specification of how, when and where the process of validation will be conducted. The premises and equipment that will be used for validation have to qualify. Testing and inspection methods must also be authorized by the validation team containing specialists in the given field.

Product Manufacturing

• The product has to be manufactured to the exact specifications outlined in the validation plan. It must be successfully manufactured in at least three consecutive batches. All processes must be carefully recorded during the manufacturing process.

Report

• After the product has been successfully manufactured, a summary report should be recorded. The report should contain all aspects of the manufacturing process. The validation team should subsequently review and approve the validation process. The team should also regularly review the data to establish if there is a need for revalidation.