The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...

In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors. In 1987, when the US Food and Drug ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...