A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality ...

The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them. In November 2008, the US Food and Drug Administration issued Draft Guidance for ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

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 ...

WavePro 700Zi series digital scopes combine an array of performance improvements, including an outstanding waveform feature finder, rare-event capture technologies, a deep toolbox, exceptional ...