Submission

October 27, 2020
What to Control; CQAs and CPPs and the Key Variables in the Regulatory Submission

What to Control; CQAs and CPPs and the Key Variables in the Regulatory Submission

The FDA’s regulatory requirements for process validation highlights the need for defining Critical Process Parameters (CPPs) based on Critical Quality Attributes (CQAs). As described by the FDA, a CQA is a characteristic within a range that ensures a specified level of product quality. These requirements highlight the focus of QbD, or Quality by Design. The ICH describes this view of quality assurance that focuses more on validating the process through control parameters and less on defining quality based on product testing.
November 10, 2020
Einstein

Does Your Program Need a CMC or CMC Regulatory Expert? Don’t Wait Too Long!

When a CMC emergency crops up, you grit your teeth, your blood pressure spikes and you pledge to bear down and make the right decision. And that’s exactly why you might make the wrong decision. In today’s biotech industry, (where MONEY and TIME, can make you or break you) it can be harder to bounce back.
February 11, 2021
Year of the Ox

Will the Year of the Ox Bring You Luck?

What daring goals did you set in 2020?  Did you reach them? 2021 is a New Year. Your year to get clear on where you're going and how to get there.