Analytical Methodology for Chemistry, Manufacturing & Controls (CMC)

Robust analytical methods are the foundation for chemistry, manufacturing and controls (CMC) projects. Testing including these methods is required to ensure the composition, safety and efficacy of drug products both before and after release.

Several best practices for expedient and successful LC test method development and validation are outlined in this white paper, and it is important to note that most of these principles apply to methods other than LC as well.

To learn more about best practices for CMC project method development, download the free white paper below.

Analytical Methodology for Chemistry, Manufacturing & Controls (CMC) includes guidance on 

• Defining your objective
• Exploring the design space
• Method qualification and validation