FDA has published final guidance documents regarding validation and development of analytical procedures. On March 7, 2024, FDA published two final guidance documents regarding analytical procedures ...

Uniform, globally accepted greenness metrics are positioned as essential; inconsistent scoring frameworks would erode ...

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

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 ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

Figure 1 shows that individual measurement values hover around a mean value and the difference between the mean value and true value is the systematic error of ...