During autumn 2001, a Delphi survey was conducted using the Internet to discover the opinions of European experts from the pharmaceutical fields of industry, regulation and academia regarding ...

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 ...

You can draw a flowchart for processes in Microsoft Excel without using an external add-on. There are mainly two methods to do so. You can use one or a combination of both methods to create a ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...