GMP

February 4, 2021
Super Bowl

What the Super Bowl Can Teach Us about CMC Strategy

It all starts with a game plan. Just like any Super Bowl contender starts with a game plan, anyone involved with drug development should too. A CMC game plan becomes your pathway to success.
April 1, 2021

Establishing Regulatory Starting Materials & Understanding the ICH

There are many ways for companies to get approvals for expedited development. This is primarily based on trials and data from clinical studies. The biggest issue has always been how acceleration impacts CMC. In many cases, the data and the programs need time and cannot be expedited. So how do you ensure CMC doesn't become the bottleneck?
December 2, 2021

Drafting a Marketing Application? Let Your Creativity Bubble Up

The Quality Modules 2 and 3 are well-defined components of the Common Technical Document (CTD) containing both drug substance (active ingredient) and drug product sections, each containing required presentations of Chemistry, Manufacturing and Controls (CMC) information, covering processes and key control parameters, and various justifications supported by qualification and validation studies.
August 3, 2022

Understanding the Relationship Between CMC & GMP

CMC information reinforces the connection between the quality of a candidate drug used in clinical studies and the end product marketed to consumers. It effectively outlines critical quality attributes across the full life cycle of drug products, from clinical development to commercial scale production. Like current good manufacturing practices (cGMP, or GMP), CMC reviews have regulatory requirements established by the US FDA. But where the goals of these two pharmaceutical control strategies are closely aligned, they differ significantly in approach and regulation.