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 ...

Product development risks can be reduced by validating project requirements before the design process begins. Trace Baker Measured in money, time, safety, and reputation, the errors that are most ...

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...

Process validation is an extension of biologics development processes. When it comes to outsourcing process validation of biologics, Abel Hastings, director of process sciences at FUJIFILM Diosynth ...

Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official ...

The rate of technological advancement is increasing faster than ever before. Although the demands for meeting aggressive time-to-market requirements and innovating at warp speed are not new, they are ...