On March 7, 2024, FDA published two final guidance documents regarding analytical procedures in order to facilitate regulatory evaluations and flexibility in postapproval change management of ...

IMGCAP(1)]Documenting audit and review procedures often feels more like administrative than value-adding work. And some procedures—like analytics, for example—require more extensive documentation due ...

ICH Q14 Draft Guideline: Analytical Procedure Development In March 2022, the ICH Q14 draft guideline was published for public consultation aiming to describe science- and risk-based approaches for ...

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 ...

Learn how benchtop NMR supports robust and flexible analytical quality control by simplifying method design and risk ...