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 ...

Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management. In 2010, the ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

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 ...